If you entered a web address please check it was correct.
\nYou can also try Search Page to find the study you are looking for.
"}}},"trialDetailsJson":{"title":"Details Page","returnSearch":"Back to search results","description":"Study Description","identifier":"ViiV Study ID","clinicalID":"Clinicaltrials.gov Identifier","EudraCtID":"EudraCT Number","resultsAvailable":"Has Results Available Below","docAvailable":"Has Results Document Available","studyOverview":"Study Overview","overviewSection":{"conditionsDisplay":"Medical Conditions","product":"Product","collaborators":"Collaborators","dates":"Date","studyType":"Type","phase":"Phase","gender":"Gender","age":"Age","acceptVolunteers":"Accepts Healthy Volunteers"},"studyDocuments":"Study Documents","noDocuments":"No documents available","studyDocumentsAdditionalText":"If you wish to request for Full Study Report, please contact - ","studyDocumentsAdditionalEmail":"GSKClinicalSupportHD@gsk.com","isReleased":{"firstPart":"This study has Protocol and Result summary on ClinicalTrial.gov. Click","secondPart":"to learn more.","linkText":"here"},"mapLocations":"Locations","centralContact":"Central Contact","centralPhone":"Central Contact Phone","centralEmail":"Central Contact Email","mapSection":{"site":"GSK Investigational Site","condition":"Condition","id":"Study ID","city":"City","state":"State","zip":"Zip","country":"Country"},"studyDesign":"Study Design","designSection":{"purpose":"Primary Purpose","allocation":"Allocation","study_design":"Study Design","study_classification":"Study Classification","masking":"Masking","masked_subject":"Masked Subject","masked_caregiver":"Masked Caregiver","masked_investigator":"Masked Investigator","masked_assessor":"Masked Assessor","primary_outcomes":"Primary Outcomes","secondary_outcomes":"Secondary Outcomes","arms":"Arms","interventions":"Interventions","keyword":"Keyword","inclusionTitle":"Inclusion Criteria","exclusionTitle":"Exclusion Criteria","criteriaText":"Inclusion/Exclusion Criteria","criteria_button":"Click to view inclusion/exclusion criteria","enrollment":"Enrollment","clinicalPublications":"Clinical Publications"},"popoversText":{"studyId":{"childMarkdownRemark":{"html":"A unique number for a study given by ViiV.
"}},"ctGov":{"childMarkdownRemark":{"html":"This number identifies the study on the US clinicaltrials.gov register. Click this link to go to the entry for this study on Clinicaltrials.gov where you will be able to see protocol and results summaries where available.
"}},"eudraCT":{"childMarkdownRemark":{"html":"This number identifies the study on the EU clinicaltrials.eu register. Click this link to go to the entry for this study on clinicaltrials.eu where you will be able to see protocol and results summaries where available.
"}}}},"site":{"siteMetadata":{"siteUrl":"https://www.viiv-studyregister.com"}},"studyDetails":{"nct_number":"NCT03441984","ctis_id":"","HasResults":"true","IpdAccessCriteria":"","IpdDescription":"","IpdInfoTypeAnalyticCode":"","IpdInfoTypeIcf":"","IpdInfoTypeCsr":"","IpdInfoTypeProtocol":"","IpdInfoTypeSap":"","IpdTimeFrame":"","IpdUrl":"http://","IsFlexibleTrial":false,"IsReleasedToCtGov":"true","MaskingInfo":{"masked_assessor":"false","masked_caregiver":"false","masked_investigator":"false","masked_subject":"false","masking_description":"This is an open-label study in healthy volunteers.","no_masking":"true"},"PatientLevelData":"false","SharingIpd":"None","acronym":"","allocation":"Randomized","arm_groups":[{"arm_group_label":"Subjects with treatment sequence ABC","arm_group_description":"The subjects in Part 1 of the study, will receive a single dose of treatment A= adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) administered as direct-to-mouth, in TP1; treatment B=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) administered as a dispersion and taken immediately in TP2; and treatment C=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) administered as direct-to-mouth in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.","arm_type":"Experimental"},{"arm_group_label":"Subjects with treatment sequence BCA","arm_group_description":"The subjects in Part 1 of the study, will receive treatment B in TP1, treatment C in TP2 and treatment A in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.","arm_type":"Experimental"},{"arm_group_label":"Subjects with treatment sequence CAB","arm_group_description":"The subjects in Part 1 of the study will receive a single dose each of, treatment C in TP1, treatment A in TP2 and treatment B in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.","arm_type":"Experimental"},{"arm_group_label":"Subjects with treatment sequence ACB","arm_group_description":"The subjects in Part 1 of the study will receive, treatment A in TP1, treatment C in TP2 and treatment B in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.","arm_type":"Experimental"},{"arm_group_label":"Subjects with treatment sequence BAC","arm_group_description":"The subjects in Part 1 of the study will receive a single dose each of, treatment B in TP1, treatment A in TP2 and treatment C in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.","arm_type":"Experimental"},{"arm_group_label":"Subjects with treatment sequence CBA","arm_group_description":"The subjects in Part 1 of the study will receive a single dose each of, treatment C in TP1, treatment B in TP2 and treatment A in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.","arm_type":"Experimental"},{"arm_group_label":"Subjects with treatment sequence DEF","arm_group_description":"The subjects in Part 2 of the study, will receive a single dose of treatment D= Adult DTG (50 mg, 1 conventional tablet) and adult 3TC (300 mg, 1 conventional tablet) administered as direct-to-mouth, in TP1; treatment E= Pediatric DTG/3TC (DTG 5 mg/3TC 30 mg, 10 dispersible tablets) administered as a dispersion and taken immediately in TP2; and treatment F= Pediatric DTG/3TC (DTG 5 mg/3TC 30 mg, 10 dispersible tablets) administered as direct-to-mouth in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.","arm_type":"Experimental"},{"arm_group_label":"Subjects with treatment sequence EFD","arm_group_description":"The subjects in Part 2 of the study, will receive a single dose respectively of treatment E in TP1, treatment F in TP2 and treatment D in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.","arm_type":"Experimental"},{"arm_group_label":"Subjects with treatment sequence FDE","arm_group_description":"The subjects in Part 2 of the study, will receive a single dose of treatment F in TP1, treatment D in TP2 and treatment E in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.","arm_type":"Experimental"},{"arm_group_label":"Subjects with treatment sequence DFE","arm_group_description":"The subjects in Part 2 of the study, will receive a single dose of treatment D in TP1, treatment F in TP2 and treatment E in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.","arm_type":"Experimental"},{"arm_group_label":"Subjects with treatment sequence EDF","arm_group_description":"The subjects in Part 2 of the study, will receive a single dose of treatment E in TP1, treatment D in TP2 and treatment F in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.","arm_type":"Experimental"},{"arm_group_label":"Subjects with treatment sequence FED","arm_group_description":"The subjects in Part 2 of the study, will receive a single dose of treatment F in TP1, treatment E in TP2 and treatment D in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.","arm_type":"Experimental"}],"assignment":"Crossover Assignment","brief_summary":"This is a 2-part, single-dose, open label, randomized 3-way cross-over study to compare BA of pediatric study drugs TRIUMEQ and (DTG/3TC) in healthy volunteers under fasted conditions. Study will be conducted in 2-parts. Each part 1 and part 2 will comprise of 3-treatment periods (TP) where Part 1, will assess BA, of pediatric TRIUMEQ dispersible tablets with an adult TRIUMEQ conventional tablet formulation and Part 2, will assess BA, of pediatric DTG/3TC dispersible tablets with adult DTG and 3TC conventional tablets formulation. Total duration of study is 9-weeks and will be conducted in approximately 36 subjects. The 2-parts, may be run in parallel as they are independent of each other. TRIUMEQ is a registered trademark of GlaxoSmithKline group of companies.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"To assess the relative bioavailability (BA) of TRIUMEQ® and dolutegravir and lamivudine (DTG/3TC) pediatric dispersible tablet formulations in healthy volunteers","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"HIV infections","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 17:28:24","criteria":"Inclusion Criteria: - Between 18 and 65 years of age, inclusive, at the time of signing the informed consent. - Healthy subjects as determined by the investigator or medically qualified designee based on a medical evaluation, including medical history, physical examination, laboratory tests, and cardiac evaluation (history and ECG). - Body weight >=50 kilogram (kg) for males and >=45 kg for females and body mass index (BMI) within the range 18.5 – 31.0 kilogram per square meter (kg/m^2) (inclusive). - Male and female subjects where the male subjects must agree to use contraception during the TP and for at least 2 weeks plus an additional 90 days (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period. For the female subjects, female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin [hCG] test), not lactating, and at least 1 of the following conditions applies: Female with non-reproductive potential, defined as Premenopausal females with one of the following like documented tubal ligation, documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, documented hysterectomy, documented bilateral oophorectomy, the Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone and estradiol levels consistent with menopause. Females on hormone replacement therapy (HRT), and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment; Females with reproductive potential and agrees to follow one of the options for avoiding pregnancy in females of reproductive potential, from 30 days prior to the first dose of study medication and until 2 weeks after dosing with study medication and completion of the follow-up visit; the investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception; All female subjects participating in the study should be counselled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of human immune virus (HIV) transmission to an uninfected partner. - Subjects capable of giving signed informed consent. - For participation in Part 1, documentation that the subject is negative for the human leukocyte antigen (HLA)-B*5701 allele. Exclusion Criteria: - The medical conditions included where ALT and bilirubin >1.5 × upper limit of normal (ULN) (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin < =35%). - Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones). - Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination) where the heart rate for the male subjects be <45 and >100 beats per minute (bpm) and that for females be < 50 and > 100 bpm; the PR interval for both be < 120 and > 220 millisecond (msec); the QRS interval be < 70 and > 120 msec and the corrected Q-T interval (QTc) obtained using the Fridericia's formula (QTcF) be >450 msec ; ECG with evidence of previous myocardial infarction (does not include ST segment changes associated with repolarization; any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular block [2nd degree or higher], Wolf-Parkinson-White syndrome); Sinus pauses > 3 seconds; any significant arrhythmia which, in the opinion of the principal investigator or ViiV/GlaxoSmithKline (GSK) medical monitor, will interfere with the safety of the individual subject; non-sustained or sustained ventricular tachycardia (3 consecutive ventricular ectopic beats). - Subjects with use of prior or concomitant therapy who are unable to refrain from the use of prescription (e.g., dofetilide) or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and ViiV Healthcare Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. - History of regular alcohol consumption within 6 months of the study, defined as an average weekly intake of >14 drinks for males or > 7 drinks for females. One drink is equivalent to 12 gram of alcohol: 12 ounces (360 milliliter [mL]) of beer, 5 ounces (150 mL) of wine, or 1.5 ounces (45 mL) of 80 proof distilled spirits. - Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 1 month prior to screening. - Contraindications like history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation. The subject has participated in a clinical trial and has received an investigational product (IP) within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the IP (whichever is longer). - The subject has participated in a clinical trial and has received an IP within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the IP (whichever is longer). - Creatinine clearance (CrCL) < 90 mL per minute. - Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. - A positive pre-study drug/alcohol/cotinine screen. - A positive test for HIV antibody. - Where participation in the study would result in donation of blood or blood product in excess of 500 mL within 60 days. - Exposure to more than four new chemical entities within 12 months prior to the first dosing day.","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 1","display_phase_internal":"PHASE_1","display_status":"Not yet recruiting","display_status_internal":"RECSTATUS_I_NOT_YET_REC","endpoint":"","enrollment":"36","exclusion":"","gender":"All","gender_based":"No","gender_description":"","healthy_volunteers":"Yes","id":"c3885f39-a95e-5770-89b3-7f2dfceded54","internal":{"content":null,"contentDigest":"cc497b8a27d9ca92a7dece5c01f2e65e","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - Between 18 and 65 years of age, inclusive, at the time of signing the informed consent. - Healthy subjects as determined by the investigator or medically qualified designee based on a medical evaluation, including medical history, physical examination, laboratory tests, and cardiac evaluation (history and ECG). - Body weight >=50 kilogram (kg) for males and >=45 kg for females and body mass index (BMI) within the range 18.5 – 31.0 kilogram per square meter (kg/m^2) (inclusive). - Male and female subjects where the male subjects must agree to use contraception during the TP and for at least 2 weeks plus an additional 90 days (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period. For the female subjects, female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin [hCG] test), not lactating, and at least 1 of the following conditions applies: Female with non-reproductive potential, defined as Premenopausal females with one of the following like documented tubal ligation, documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, documented hysterectomy, documented bilateral oophorectomy, the Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone and estradiol levels consistent with menopause. Females on hormone replacement therapy (HRT), and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment; Females with reproductive potential and agrees to follow one of the options for avoiding pregnancy in females of reproductive potential, from 30 days prior to the first dose of study medication and until 2 weeks after dosing with study medication and completion of the follow-up visit; the investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception; All female subjects participating in the study should be counselled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of human immune virus (HIV) transmission to an uninfected partner. - Subjects capable of giving signed informed consent. - For participation in Part 1, documentation that the subject is negative for the human leukocyte antigen (HLA)-B*5701 allele. Exclusion Criteria: - The medical conditions included where ALT and bilirubin >1.5 × upper limit of normal (ULN) (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin < =35%). - Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones). - Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination) where the heart rate for the male subjects be <45 and >100 beats per minute (bpm) and that for females be < 50 and > 100 bpm; the PR interval for both be < 120 and > 220 millisecond (msec); the QRS interval be < 70 and > 120 msec and the corrected Q-T interval (QTc) obtained using the Fridericia's formula (QTcF) be >450 msec ; ECG with evidence of previous myocardial infarction (does not include ST segment changes associated with repolarization; any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular block [2nd degree or higher], Wolf-Parkinson-White syndrome); Sinus pauses > 3 seconds; any significant arrhythmia which, in the opinion of the principal investigator or ViiV/GlaxoSmithKline (GSK) medical monitor, will interfere with the safety of the individual subject; non-sustained or sustained ventricular tachycardia (3 consecutive ventricular ectopic beats). - Subjects with use of prior or concomitant therapy who are unable to refrain from the use of prescription (e.g., dofetilide) or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and ViiV Healthcare Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. - History of regular alcohol consumption within 6 months of the study, defined as an average weekly intake of >14 drinks for males or > 7 drinks for females. One drink is equivalent to 12 gram of alcohol: 12 ounces (360 milliliter [mL]) of beer, 5 ounces (150 mL) of wine, or 1.5 ounces (45 mL) of 80 proof distilled spirits. - Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 1 month prior to screening. - Contraindications like history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation. The subject has participated in a clinical trial and has received an investigational product (IP) within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the IP (whichever is longer). - The subject has participated in a clinical trial and has received an IP within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the IP (whichever is longer). - Creatinine clearance (CrCL) < 90 mL per minute. - Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. - A positive pre-study drug/alcohol/cotinine screen. - A positive test for HIV antibody. - Where participation in the study would result in donation of blood or blood product in excess of 500 mL within 60 days. - Exposure to more than four new chemical entities within 12 months prior to the first dosing day.","interventions":[{"arm_group_label":"Subjects with treatment sequence CAB","intervention_description":"TRIUMEQ (Adult) administered as a, single dose, fixed dose combination (FDC) tablet – DTG 50 mg/ABC 600 mg/3TC 300 mg as 1 conventional tablet, orally as direct-to-mouth.","intervention_name":"Treatment A","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence ABC","intervention_description":"TRIUMEQ (Adult) administered as a, single dose, fixed dose combination (FDC) tablet – DTG 50 mg/ABC 600 mg/3TC 300 mg as 1 conventional tablet, orally as direct-to-mouth.","intervention_name":"Treatment A","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence ACB","intervention_description":"TRIUMEQ (Adult) administered as a, single dose, fixed dose combination (FDC) tablet – DTG 50 mg/ABC 600 mg/3TC 300 mg as 1 conventional tablet, orally as direct-to-mouth.","intervention_name":"Treatment A","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence BAC","intervention_description":"TRIUMEQ (Adult) administered as a, single dose, fixed dose combination (FDC) tablet – DTG 50 mg/ABC 600 mg/3TC 300 mg as 1 conventional tablet, orally as direct-to-mouth.","intervention_name":"Treatment A","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence CBA","intervention_description":"TRIUMEQ (Adult) administered as a, single dose, fixed dose combination (FDC) tablet – DTG 50 mg/ABC 600 mg/3TC 300 mg as 1 conventional tablet, orally as direct-to-mouth.","intervention_name":"Treatment A","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence BCA","intervention_description":"TRIUMEQ (Adult) administered as a, single dose, fixed dose combination (FDC) tablet – DTG 50 mg/ABC 600 mg/3TC 300 mg as 1 conventional tablet, orally as direct-to-mouth.","intervention_name":"Treatment A","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence CAB","intervention_description":"TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet – DTG 5 mg/ABC 60 mg/ 3TC 30 mg, orally as 10 dispersible tablets","intervention_name":"Treatment B","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence ABC","intervention_description":"TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet – DTG 5 mg/ABC 60 mg/ 3TC 30 mg, orally as 10 dispersible tablets","intervention_name":"Treatment B","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence ACB","intervention_description":"TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet – DTG 5 mg/ABC 60 mg/ 3TC 30 mg, orally as 10 dispersible tablets","intervention_name":"Treatment B","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence BAC","intervention_description":"TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet – DTG 5 mg/ABC 60 mg/ 3TC 30 mg, orally as 10 dispersible tablets","intervention_name":"Treatment B","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence CBA","intervention_description":"TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet – DTG 5 mg/ABC 60 mg/ 3TC 30 mg, orally as 10 dispersible tablets","intervention_name":"Treatment B","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence BCA","intervention_description":"TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet – DTG 5 mg/ABC 60 mg/ 3TC 30 mg, orally as 10 dispersible tablets","intervention_name":"Treatment B","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence CAB","intervention_description":"TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet – DTG 5 mg/ABC 60 mg/3TC 30 mg, orally as direct-to-mouth.","intervention_name":"Treatment C","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence ABC","intervention_description":"TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet – DTG 5 mg/ABC 60 mg/3TC 30 mg, orally as direct-to-mouth.","intervention_name":"Treatment C","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence ACB","intervention_description":"TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet – DTG 5 mg/ABC 60 mg/3TC 30 mg, orally as direct-to-mouth.","intervention_name":"Treatment C","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence BAC","intervention_description":"TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet – DTG 5 mg/ABC 60 mg/3TC 30 mg, orally as direct-to-mouth.","intervention_name":"Treatment C","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence CBA","intervention_description":"TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet – DTG 5 mg/ABC 60 mg/3TC 30 mg, orally as direct-to-mouth.","intervention_name":"Treatment C","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence BCA","intervention_description":"TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet – DTG 5 mg/ABC 60 mg/3TC 30 mg, orally as direct-to-mouth.","intervention_name":"Treatment C","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence EFD","intervention_description":"DTG and 3TC (Adult), administered as a, single dose, Single dose, 1 tablet DTG (50 mg) and 1 tablet 3TC (300 mg), orally as direct-to-mouth.","intervention_name":"Treatment D","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence FED","intervention_description":"DTG and 3TC (Adult), administered as a, single dose, Single dose, 1 tablet DTG (50 mg) and 1 tablet 3TC (300 mg), orally as direct-to-mouth.","intervention_name":"Treatment D","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence DFE","intervention_description":"DTG and 3TC (Adult), administered as a, single dose, Single dose, 1 tablet DTG (50 mg) and 1 tablet 3TC (300 mg), orally as direct-to-mouth.","intervention_name":"Treatment D","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence FDE","intervention_description":"DTG and 3TC (Adult), administered as a, single dose, Single dose, 1 tablet DTG (50 mg) and 1 tablet 3TC (300 mg), orally as direct-to-mouth.","intervention_name":"Treatment D","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence DEF","intervention_description":"DTG and 3TC (Adult), administered as a, single dose, Single dose, 1 tablet DTG (50 mg) and 1 tablet 3TC (300 mg), orally as direct-to-mouth.","intervention_name":"Treatment D","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence EDF","intervention_description":"DTG and 3TC (Adult), administered as a, single dose, Single dose, 1 tablet DTG (50 mg) and 1 tablet 3TC (300 mg), orally as direct-to-mouth.","intervention_name":"Treatment D","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence EFD","intervention_description":"DTG and 3TC (Pediatric) administered as a, single dose, FDC tablet single dose, FDC tablet – DTG 5 mg/3TC 30 mg, orally as 10 dispersible tablets.","intervention_name":"Treatment E","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence DFE","intervention_description":"DTG and 3TC (Pediatric) administered as a, single dose, FDC tablet single dose, FDC tablet – DTG 5 mg/3TC 30 mg, orally as 10 dispersible tablets.","intervention_name":"Treatment E","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence FDE","intervention_description":"DTG and 3TC (Pediatric) administered as a, single dose, FDC tablet single dose, FDC tablet – DTG 5 mg/3TC 30 mg, orally as 10 dispersible tablets.","intervention_name":"Treatment E","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence DEF","intervention_description":"DTG and 3TC (Pediatric) administered as a, single dose, FDC tablet single dose, FDC tablet – DTG 5 mg/3TC 30 mg, orally as 10 dispersible tablets.","intervention_name":"Treatment E","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence EDF","intervention_description":"DTG and 3TC (Pediatric) administered as a, single dose, FDC tablet single dose, FDC tablet – DTG 5 mg/3TC 30 mg, orally as 10 dispersible tablets.","intervention_name":"Treatment E","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence EFD","intervention_description":"DTG and 3TC (Pediatric) administered as a, single dose, FDC tablet single dose, FDC tablet – DTG 5 mg/3TC 30 mg, orally as direct-to-mouth.","intervention_name":"Treatment F","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence FED","intervention_description":"DTG and 3TC (Pediatric) administered as a, single dose, FDC tablet single dose, FDC tablet – DTG 5 mg/3TC 30 mg, orally as direct-to-mouth.","intervention_name":"Treatment F","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence DFE","intervention_description":"DTG and 3TC (Pediatric) administered as a, single dose, FDC tablet single dose, FDC tablet – DTG 5 mg/3TC 30 mg, orally as direct-to-mouth.","intervention_name":"Treatment F","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence FDE","intervention_description":"DTG and 3TC (Pediatric) administered as a, single dose, FDC tablet single dose, FDC tablet – DTG 5 mg/3TC 30 mg, orally as direct-to-mouth.","intervention_name":"Treatment F","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence DEF","intervention_description":"DTG and 3TC (Pediatric) administered as a, single dose, FDC tablet single dose, FDC tablet – DTG 5 mg/3TC 30 mg, orally as direct-to-mouth.","intervention_name":"Treatment F","intervention_type":"Drug"},{"arm_group_label":"Subjects with treatment sequence EDF","intervention_description":"DTG and 3TC (Pediatric) administered as a, single dose, FDC tablet single dose, FDC tablet – DTG 5 mg/3TC 30 mg, orally as direct-to-mouth.","intervention_name":"Treatment F","intervention_type":"Drug"}],"interventional_subtype":"Treatment","is_fda_regulated":true,"is_high_value":false,"is_ind_study":true,"keywords":["Pediatric dispersible tablets","Bioavailability"],"last_follow_up_date":"05/04/2018 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"65 years","maximum_age":"65","minimum_age":"18","minimum_age_raw":"18 years","modified_date":"06/18/2024 13:28:14","number_of_arms":"12","observational_design":{"biospecimen_description":"","biospecimen_retention":"","number_of_groups":"","observational_study_design":"","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":""},"official_title":"A 2-Part, Phase I, Single-Dose, 3-Period Crossover Relative Bioavailability Study of a Pediatric TRIUMEQ Dispersible Tablet and Pediatric Dolutegravir and Lamivudine (DTG/3TC) Fixed Dose Combination Dispersible Tablet Formulations as Compared With Adult Tablets in Healthy Volunteers","org_study_id":"205894","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Not yet recruiting - Interventional","oversight_info":{"exported_from_us":"","fda_regulated_device":"No","fda_regulated_drug":"Yes","ped_postmarket_surv":"","has_dmc":false,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"1","primary_compl_date":"04/17/2018 00:00:00","primary_outcomes":[{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: Area under the plasma concentration-time curve (AUC) from time of dose extrapolated to infinity (AUC [0-inf] ) for DTG 50 mg- following adult TRIUMEQ conventional tablet – direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: AUC (0-inf) for ABC 600 mg- following adult TRIUMEQ conventional tablet – direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: AUC (0-inf) for 3TC 300 mg- following adult TRIUMEQ conventional tablet – direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: AUC (0-inf) for DTG 5 mg-following pediatric TRIUMEQ dispersible tablets - dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: AUC (0-inf) for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets - dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1:AUC (0-inf) for 3TC 30 mg-following pediatric TRIUMEQ dispersible tablets - dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: AUC (0-inf) for DTG 5 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: AUC (0-inf) for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: AUC (0-inf) for 3TC 30 mg-following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: AUC from time of dose to last measurable concentration (AUC [0-t]) for DTG 50 mg- following adult TRIUMEQ conventional tablet – direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: AUC (0-t) for ABC 600 mg- following adult TRIUMEQ conventional tablet – direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: AUC (0-t) for 3TC 300 mg- following adult TRIUMEQ conventional tablet – direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: AUC (0-t) for DTG 5 mg-following pediatric TRIUMEQ dispersible tablets - dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: AUC (0-t) for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets - dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: AUC (0-t) for 3TC 30 mg-following pediatric TRIUMEQ dispersible tablets - dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: AUC (0-t) for DTG 5 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: AUC (0-t) for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: AUC (0-t) for 3TC 30 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: Maximum observed concentration (Cmax) for DTG 50 mg- following adult TRIUMEQ conventional tablet – direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: Cmax for ABC 600 mg- following adult TRIUMEQ conventional tablet – direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: Cmax for 3TC 300 mg- following adult TRIUMEQ conventional tablet – direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: Cmax for DTG 5 mg-following pediatric TRIUMEQ dispersible tablets - dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: Cmax for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets - dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: Cmax for 3TC 30 mg-following pediatric TRIUMEQ dispersible tablets - dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: Cmax for DTG 5 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: Cmax for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 1: Cmax for 3TC 30 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 2: AUC (0-inf) for DTG 50 mg- following adult conventional DTG tablets - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 2: AUC (0-inf) for 3TC 300 mg- following adult conventional 3TC tablets - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 2: AUC (0-inf) for DTG 5 mg-following pediatric DTG dispersible tablets -dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 2: AUC (0-inf) for 3TC 30 mg-following pediatric 3TC dispersible tablets -dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 2: AUC (0-inf) for DTG 5 mg- following pediatric DTG dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 2: AUC (0-inf) for 3TC 30 mg- following pediatric 3TC dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 2: AUC (0-t) for DTG 50 mg- following adult conventional DTG tablets - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 2: AUC (0-t) for 3TC 300 mg- following adult conventional 3TC tablets - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 2: AUC (0-t) for DTG 5 mg- following pediatric DTG dispersible tablets -dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 2: AUC (0-t) for 3TC 30 mg-following pediatric 3TC dispersible tablets -dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 2: AUC (0-t) for DTG 5 mg- following pediatric DTG dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 2: AUC (0-t) for 3TC 30 mg- following pediatric 3TC dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 2: Cmax for DTG 50 mg- following adult conventional DTG tablets - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 2: Cmax for 3TC 300 mg- following adult conventional 3TC tablets - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 2: Cmax for DTG 5 mg- following pediatric DTG dispersible tablets -dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 2: Cmax for 3TC 30 mg-following pediatric 3TC dispersible tablets -dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 2: Cmax for DTG 5 mg- following pediatric DTG dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for analysis.","outcome_measure":"Part 2: Cmax for 3TC 30 mg- following pediatric 3TC dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: AUC from time of dose to 24 hours (AUC[0-24]) for DTG 50 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: AUC (0-24) for ABC 600 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: AUC (0-24) for 3TC 300 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: AUC (0-24) for DTG 5 mg- following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: AUC (0-24) for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: AUC (0-24) for 3TC 30 mg-following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: AUC (0-24) for DTG 5 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: AUC (0-24) for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: AUC (0-24) for 3TC 30 mg-following pediatric TRIUMEQ dispersible tablets –direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Time to maximum concentration (Tmax) for DTG 50 mg- direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Tmax for ABC 600 mg- direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Tmax for 3TC 300 mg- direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Tmax for DTG 5 mg-following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Tmax for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Tmax for 3TC 30 mg-following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Tmax for DTG 5 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Tmax for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Tmax for 3TC 30 mg- following pediatric TRIUMEQ dispersible tablets- direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Time of last quantifiable concentration (Tlast) for DTG 50 mg-following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Tlast for ABC 600 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Tlast for 3TC 300 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Tlast for DTG 5 mg-following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Tlast for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Tlast for 3TC 30 mg-following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Tlast for DTG 5 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Tlast for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Tlast for 3TC 30 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Apparent oral clearance (CL/F) for DTG 50 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: CL/F for ABC 600 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: CL/F for 3TC 300 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: CL/F for DTG 5 mg-following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: CL/F for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: CL/F for 3TC 30 mg-following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: CL/F for DTG 5 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: CL/F for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: CL/F for 3TC 30 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Apparent volume of distribution (Vz/F) for DTG 50 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Vz/F for ABC 600 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Vz/F for 3TC 300 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Vz/F for DTG 5 mg-following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Vz/F for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Vz/F for 3TC 30 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Vz/F for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets-dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Vz/F for 3TC 30 mg- following pediatric TRIUMEQ dispersible tablets-dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Vz/F for DTG 5 mg- following pediatric TRIUMEQ dispersible tablets direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Observed concentration at 24 hours postdose (C24) DTG 50 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: C24 for ABC 600 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: C24 for 3TC 300 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: C24 for DTG 5 mg-following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: C24 for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: C24 for 3TC 30 mg-following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: C24 for DTG 5 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: C24 for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: C24 for 3TC 30 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Last observed quantifiable concentration (Ct) for DTG 50 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Ct for ABC 600 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Ct for 3TC 300 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Ct for DTG 5 mg- following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Ct for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Ct for 3TC 30 mg- following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Ct for DTG 5 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Ct for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Ct for 3TC 30 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Terminal elimination phase half-life (t½) for DTG 50 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: t½ for ABC 600 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: t½ for 3TC 300 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: t½ for DTG 5 mg- following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: t½ for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: t½ for 3TC 30 mg- following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: t½ for DTG 5 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: t½ for ABC 60 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: t½ for 3TC 30 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: Lag time for absorption (tlag) for DTG 50 mg- following adult TRIUMEQ conventional tablet - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: tlag for DTG 5 mg- following pediatric TRIUMEQ dispersible tablets – dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 1: tlag for DTG 5 mg- following pediatric TRIUMEQ dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: AUC(0-24) for DTG 50 mg- following adult conventional DTG tablets - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: AUC(0-24) for 3TC 300 mg- following adult conventional 3TC tablets - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: AUC(0-24) for DTG 5 mg-following pediatric DTG dispersible tablets –dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: AUC(0-24) for 3TC 30 mg-following pediatric 3TC dispersible tablets –dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: AUC(0-24) for DTG 5 mg- following pediatric DTG dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: AUC(0-24) for 3TC 30 mg- following pediatric 3TC dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: Tmax for DTG 50 mg-following adult conventional DTG tablets - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: Tmax for 3TC 300 mg-following adult conventional 3TC tablets - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: Tmax for DTG 5 mg- following pediatric DTG dispersible tablets –dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: Tmax for 3TC 30 mg- following pediatric 3TC dispersible tablets –dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: Tmax for DTG 5 mg- following pediatric DTG dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: Tmax for 3TC 30 mg- following pediatric 3TC dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: CL/F for DTG 50 mg- following adult conventional DTG tablets - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: CL/F for 3TC 300 mg- following adult conventional 3TC tablets - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: CL/F for DTG 5 mg- following pediatric DTG dispersible tablets –dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: CL/F for 3TC 30 mg- following pediatric 3TC dispersible tablets –dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: CL/F for DTG 5 mg- following pediatric DTG dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: CL/F for 3TC 30 mg- following pediatric 3TC dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: Vz/F for DTG 50 mg- following adult conventional DTG tablets - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: Vz/F for 3TC 300 mg- following adult conventional 3TC tablets - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: Vz/F for DTG 5 mg- following pediatric DTG dispersible tablets –dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: Vz/F for 3TC 30 mg- following pediatric 3TC dispersible tablets –dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: Vz/F for DTG 5 mg- following pediatric DTG dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: Vz/F for 3TC 30 mg- following pediatric 3TC dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: C24 for DTG 50 mg- following adult conventional DTG tablets - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: C24 for 3TC 300 mg- following adult conventional 3TC tablets - direct to mou","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: C24 for DTG 5 mg- following pediatric DTG dispersible tablets –dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: C24 for 3TC 30 mg- following pediatric 3TC dispersible tablets –dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: C24 for DTG 5 mg- following pediatric DTG dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: C24 for 3TC 30 mg- following pediatric 3TC dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: Ct for DTG 50 mg- following adult conventional DTG tablets - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: Ct for 3TC 300 mg- following adult conventional 3TC tablets - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: Ct for DTG 5 mg- following pediatric DTG dispersible tablets –dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: Ct for 3TC 30 mg- following pediatric 3TC dispersible tablets –dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: Ct for DTG 5 mg- following pediatric DTG dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: Ct for 3TC 30 mg- following pediatric 3TC dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: t (1/2) for DTG 50 mg- following adult conventional DTG tablets - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: t (1/2) for 3TC 300 mg- following adult conventional 3TC tablets - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: t (1/2) for DTG 5 mg- following pediatric DTG dispersible tablets –dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: t (1/2) for 3TC 30 mg- following pediatric 3TC dispersible tablets –dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: t (1/2) for DTG 5 mg-following pediatric DTG dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: t (1/2) for 3TC 30 mg- following pediatric 3TC dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: tlag for DTG 50 mg- following adult conventional 3TC tablets - direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: tlag for DTG 5 mg- following pediatric DTG dispersible tablets –dispersion","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"Whole blood samples of approximately 2 mL will be collected for PK analysis.","outcome_measure":"Part 2: tlag for DTG 5 mg- following pediatric DTG dispersible tablets-direct to mouth","outcome_time_frame":"Pre-dose, 0.25 hour, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose before discharge at the end of each TP","outcome_safety_issue":null},{"outcome_description":"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect and other situations which involve medical or scientific judgment, for Part 1 and Part 2.","outcome_measure":"Number of subjects with serious adverse events (SAE) and adverse events (AE)","outcome_time_frame":"Up to 25 days","outcome_safety_issue":null},{"outcome_description":"SBP and DBP will be measured in supine or semi-supine position after 5 minutes rest, for Part 1 and Part 2.","outcome_measure":"Absolute values of systolic blood pressure (SBP) and diastolic blood pressure (DBP)","outcome_time_frame":"Up to 25 days","outcome_safety_issue":null},{"outcome_description":"Heart rate will be measured in supine or semi-supine position after 5 minutes rest, for Part 1 and Part 2.","outcome_measure":"Absolute values of heart rate","outcome_time_frame":"Up to 25 days","outcome_safety_issue":null},{"outcome_description":"Temperature will be measured in supine or semi-supine position after 5 minutes rest, for Part 1 and Part 2.","outcome_measure":"Absolute values of temperature","outcome_time_frame":"Up to 25 days","outcome_safety_issue":null},{"outcome_description":"Twelve-lead ECGs will be performed with the subject in a supine or semi-supine position, having rested in this position for at least 10 minutes beforehand using an automated ECG machine, for Part 1 and Part 2.","outcome_measure":"Absolute values of electrocardiogram (ECG) parameters","outcome_time_frame":"Day -1 of each TP","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure of platelets, WBC count, basophils, eosinophils, lymphocytes, monocytes and neutrophils, for Part 1 and Part 2.","outcome_measure":"Absolute values of the hematology parameters of platelets, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes and neutrophils","outcome_time_frame":"Up to 25 days","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure RBC count, for Part 1 and Part 2.","outcome_measure":"Absolute values of the hematology parameter of red blood cell (RBC) count","outcome_time_frame":"Up to 25 days","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure MCH, for Part 1 and Part 2","outcome_measure":"Absolute values of the hematology parameter of mean corpuscular hemoglobin (MCH)","outcome_time_frame":"Up to 25 days","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure MCV, for Part 1 and Part 2.","outcome_measure":"Absolute values of the hematology parameter of mean corpuscular volume (MCV)","outcome_time_frame":"Up to 25 days","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure hemoglobin, for Part 1 and Part 2.","outcome_measure":"Absolute values of the hematology parameters of hemoglobin","outcome_time_frame":"Up to 25 days","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure hematocrit, for Part 1 and Part 2.","outcome_measure":"Absolute values of hematology parameter of hematocrit","outcome_time_frame":"Up to 25 days","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure sodium, potassium, glucose, and calcium, for Part 1 and Part 2.","outcome_measure":"Absolute values of clinical chemistry laboratory parameters of sodium, potassium, glucose, and calcium","outcome_time_frame":"Up to 25 days","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure BUN, direct bilirubin and indirect bilirubin for Part 1 and Part 2.","outcome_measure":"Absolute values of clinical chemistry laboratory parameters of Blood urea nitrogen (BUN), direct bilirubin and indirect bilirubin","outcome_time_frame":"Up to 25 days","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure total protein and albumin, for Part 1 and Part 2.","outcome_measure":"Absolute values of clinical chemistry laboratory parameters of total protein and albumin","outcome_time_frame":"Up to 25 days","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure creatinine, for Part 1 and Part 2.","outcome_measure":"Absolute values of clinical chemistry laboratory parameters of creatinine","outcome_time_frame":"Up to 25 days","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure ALT, AST, CPK and ALP, for Part 1 and Part 2.","outcome_measure":"Absolute values of clinical chemistry laboratory parameters of alanine amino transferase (ALT), Aspartate aminotransferase (AST), Creatine phosphokinase (CPK) and Alkaline phosphatase (ALP)","outcome_time_frame":"Up to 25 days","outcome_safety_issue":null},{"outcome_description":"SBP and DBP will be measured in supine or semi-supine position after 5 minutes rest, for Part 1 and Part 2.","outcome_measure":"Change from Baseline in SBP and DBP","outcome_time_frame":"Baseline and up to Day 25","outcome_safety_issue":null},{"outcome_description":"Heart rate will be measured in supine or semi-supine position after 5 minutes rest, for Part 1 and Part 2.","outcome_measure":"Change from Baseline in heart rate","outcome_time_frame":"Baseline and up to Day 25","outcome_safety_issue":null},{"outcome_description":"Temperature will be measured in supine or semi-supine position after 5 minutes rest, for Part 1 and Part 2.","outcome_measure":"Change from Baseline in temperature","outcome_time_frame":"Baseline and up to Day 25","outcome_safety_issue":null},{"outcome_description":"Twelve-lead ECGs will be performed with the subject in a supine or semi-supine position, having rested in this position for at least 10 minutes beforehand using an automated ECG machine, for Part 1 and Part 2.","outcome_measure":"Change from Baseline in ECG parameters","outcome_time_frame":"Baseline and up to Day 25","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure hematology parameters of platelets, WBC count, basophils, eosinophils, lymphocytes, monocytes and neutrophils, for Part 1 and Part 2.","outcome_measure":"Change from Baseline in the hematology parameters of platelets, WBC count, basophils, eosinophils, lymphocytes, monocytes and neutrophils","outcome_time_frame":"Baseline and up to Day 25","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure RBC count for Part 1 and Part 2.","outcome_measure":"Change from Baseline in the hematology parameter of RBC count","outcome_time_frame":"Baseline and up to Day 25","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure MCH for Part 1 and Part 2.","outcome_measure":"Change from Baseline in the hematology parameter of MCH","outcome_time_frame":"Baseline and up to Day 25","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure MCV, for Part 1 and Part 2.","outcome_measure":"Change from Baseline in the hematology parameter of MCV","outcome_time_frame":"Baseline and up to Day 25","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure hemoglobin, for Part 1 and Part 2.","outcome_measure":"Change from Baseline in the hematology parameters of hemoglobin","outcome_time_frame":"Baseline and up to Day 25","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure hematocrit, for Part 1 and Part 2.","outcome_measure":"Change from Baseline in hematology parameter of hematocrit","outcome_time_frame":"Baseline and up to Day 25","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure sodium, potassium, glucose, and calcium, for Part 1 and Part 2.","outcome_measure":"Change from Baseline in clinical chemistry laboratory parameters of sodium, potassium, glucose, and calcium","outcome_time_frame":"Baseline and up to Day 25","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure BUN, direct bilirubin and indirect bilirubin, for Part 1 and Part 2.","outcome_measure":"Change from Baseline in clinical chemistry laboratory parameters for BUN, direct bilirubin and indirect bilirubin","outcome_time_frame":"Baseline and up to Day 25","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure total protein and albumin, for Part 1 and Part 2.","outcome_measure":"Change from Baseline in clinical chemistry laboratory parameters of total protein and albumin","outcome_time_frame":"Baseline and up to Day 25","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure creatinine, for Part 1 and Part 2.","outcome_measure":"Change from Baseline in clinical chemistry laboratory parameters of creatinine","outcome_time_frame":"Baseline and up to Day 25","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected to measure ALT, AST, CPK and ALP, for Part 1 and Part 2.","outcome_measure":"Change from Baseline in clinical chemistry laboratory parameters of ALT, AST, CPK and ALP","outcome_time_frame":"Baseline and up to Day 25","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["GlaxoSmithKline (GSK)","Pharmaceutical Product Development (PPD), Inc"]},"start_date":"02/21/2018 00:00:00","study_type":"Interventional","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":true}},"pageContext":{"studyId":"205894"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}