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"}}},"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":"NCT03231943","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":"true","masked_subject":"true","masking_description":"This will be a double-blind study with subjects and the site-staff blinded and sponsor unblinded.","no_masking":"false"},"PatientLevelData":"false","SharingIpd":"None","acronym":"","allocation":"Randomized","arm_groups":[{"arm_group_label":"Subjects in cohort 1-2: Part 1","arm_group_description":"Eligible subjects will participate in cohort 1 or 2 and each of these two cohorts will contain up to four escalating doses of GSK3640254. In each cohort, 6 subjects will be randomized to receive single oral dose of GSK3640254 and 2 subjects will be randomized to receive placebo. Hence, each subject in cohort 1 and 2 will receive up to 3 escalating doses of GSK3640254 and one placebo in crossover manner.","arm_type":"Experimental"},{"arm_group_label":"GSK3640254 receivers (cohort 3-6 and expansion): Part 2","arm_group_description":"Eligible subjects will participate in one of the 4 cohorts (3,4,5,6). In each cohort, 6 subjects will be randomized to receive a once-daily oral dose of GSK3640254 for 14 days. After the safety data of cohort 3-6 is available, 18 eligible subjects will be randomized to receive once daily oral dose of GSK3640254 for 14 days in expansion cohort.","arm_type":"Experimental"},{"arm_group_label":"Subjects receiving placebo (cohort 3-6): Part 2","arm_group_description":"Eligible subjects will participate in one of the 4 cohorts (3,4,5,6). In each cohort, 2 subjects will be randomized to receive a once-daily oral dose of placebo for 14 days. After the safety data of cohort 3-6 is available, 6 eligible subjects will be randomized to receive once daily oral dose of placebo for 14 days in expansion cohort.","arm_type":"Placebo Comparator"}],"assignment":"Sequential Assignment","brief_summary":"Human immuno deficiency virus 1 (HIV-1) infections continues to be a serious health threat throughout the world and development of medicines with new mechanism of action have an important role to play. GSK3640254 is a maturation inhibitor (MI) and can be effective in HIV-1 treatment. This randomized, 2-part, single and repeat increasing dose study will collect information on safety, tolerability and drug levels in the body of in healthy subjects for GSK3640254. The information collected in this study will help in further clinical development of GSK3640254, including a Phase IIA Proof of Concept (PoC) study in HIV-infected subjects. Approximately 16 healthy subjects will be randomized to receive single oral dose of GSK3640254 and placebo in Part 1 and approximately 56 healthy subjects will be randomized to receive repeat oral dose of GSK3640254 or placebo in Part 2. All doses will be given immediately after a moderate fat meal. Maximum duration of study participation will be approximately 12 weeks.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"GSK3640254 first time in human (FTIH) study in healthy volunteers","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 17:29:18","criteria":"Inclusion Criteria: - Subjects must be 18 to 55 years of age inclusive, at the time of signing the informed consent. - Subjects who are overtly healthy as determined by medical evaluation including medical history and psychiatric history, physical examination, laboratory tests, and 24 hour Holter monitoring. - Body weight >=50.0 kilogram (kg) (110 pounds) for men and 45.0kg (99 pounds) for women and body mass index (BMI) within the range 18.5-32.0 kg per meter square (kg/m^2) (inclusive). - Male or female subjects. A male subject must agree to use contraception during the treatment period and for at least 14 weeks following the last dose, corresponding to the time needed to eliminate study treatment for potential genotoxic and teratogenic study treatments plus an additional 90 days (spermatogenesis cycle). In addition, male subjects must refrain from donating sperm during this period. A female subject is eligible to participate if she is not a woman of childbearing potential (WOCBP). - Capable of giving signed informed consent. Exclusion Criteria: - Alanine transaminase (ALT) >1.5 into upper limit of normal (ULN). - Bilirubin >1.5 into ULN (isolated bilirubin >1.5 into ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). - Current or chronic history of liver disease, or known hepatic or biliary abnormalities. - Pre-existing clinically relevant, in the opinion of the primary investigator (PI), gastro-intestinal pathology or diagnosis – example irritable bowel syndrome, inflammatory bowel disease, and/or significant Baseline signs and symptoms. - Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome. - Any known or suspected pre-existing psychiatric condition. - Any other clinical condition (including but not limited to active substance use) or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits; or a condition that could affect the absorption, distribution, metabolism or excretion of the drug. - Unable to refrain from the use of prescription or non-prescription drugs (with the exception of paracetamol), 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 and for the duration of the study, unless in the opinion of the Investigator and ViiV Healthcare Sponsor and medical monitor, the medication will not interfere with the study medications, procedures, or compromise subject safety. - Unwillingness to abstain from ingestion of any food or drink containing grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos within 7 days prior to the first dose of study treatment(s) or until the end of the study. - Participation in another concurrent clinical study or prior clinical study (with the exception of imaging trials) 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 investigational product (whichever is longer). - Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within 56 days. - Presence of hepatitis B surface antigen (HBsAg), or 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 screen. - A positive test for a diagnostic HIV-1 polymerase chain reaction (PCR). - Exposure to more than four new chemical entities within 12 months prior to the first dosing day. - Exclusion criteria for screening ECG: Heart rate <45 or >100 beats per minute (bpm) for males and <50 or >100 bpm for females; PR interval <120 or >220 millisecond (msec); QRS duration <70 or >120 msec; the Fridericia's QT correction formula (QTcF) interval >450 msec. - Evidence of previous myocardial infarction (does not include ST segment changes associated with re-polarization). - Any conduction abnormality (including but not specific to left or right complete bundle branch block, Atrioventricular block [2nd degree or higher], Wolff-Parkinson-White [WPW] syndrome). - Sinus Pauses >3 seconds. - Any significant arrhythmia which, in the opinion of the Investigator or GlaxoSmithKline/ViiV medical monitor, will interfere with the safety for the individual subject. - Non-sustained or sustained ventricular tachycardia (3 consecutive ventricular ectopic beats). - History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 units. One unit is equivalent to 8 gram of alcohol: a half-pint approximately 240 mL of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits. - Regular use of tobacco- or nicotine-containing products within 3 months prior to screening. - 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.","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 1","display_phase_internal":"PHASE_1","display_status":"Recruiting","display_status_internal":"RECSTATUS_RECRUITING","endpoint":"","enrollment":"80","exclusion":"","gender":"All","gender_based":"No","gender_description":"","healthy_volunteers":"Yes","id":"b1c83701-33d5-591a-92d7-dd582b871ec4","internal":{"content":null,"contentDigest":"54a0af5a35692a7235d03d98c9646d06","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - Subjects must be 18 to 55 years of age inclusive, at the time of signing the informed consent. - Subjects who are overtly healthy as determined by medical evaluation including medical history and psychiatric history, physical examination, laboratory tests, and 24 hour Holter monitoring. - Body weight >=50.0 kilogram (kg) (110 pounds) for men and 45.0kg (99 pounds) for women and body mass index (BMI) within the range 18.5-32.0 kg per meter square (kg/m^2) (inclusive). - Male or female subjects. A male subject must agree to use contraception during the treatment period and for at least 14 weeks following the last dose, corresponding to the time needed to eliminate study treatment for potential genotoxic and teratogenic study treatments plus an additional 90 days (spermatogenesis cycle). In addition, male subjects must refrain from donating sperm during this period. A female subject is eligible to participate if she is not a woman of childbearing potential (WOCBP). - Capable of giving signed informed consent. Exclusion Criteria: - Alanine transaminase (ALT) >1.5 into upper limit of normal (ULN). - Bilirubin >1.5 into ULN (isolated bilirubin >1.5 into ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). - Current or chronic history of liver disease, or known hepatic or biliary abnormalities. - Pre-existing clinically relevant, in the opinion of the primary investigator (PI), gastro-intestinal pathology or diagnosis – example irritable bowel syndrome, inflammatory bowel disease, and/or significant Baseline signs and symptoms. - Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome. - Any known or suspected pre-existing psychiatric condition. - Any other clinical condition (including but not limited to active substance use) or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits; or a condition that could affect the absorption, distribution, metabolism or excretion of the drug. - Unable to refrain from the use of prescription or non-prescription drugs (with the exception of paracetamol), 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 and for the duration of the study, unless in the opinion of the Investigator and ViiV Healthcare Sponsor and medical monitor, the medication will not interfere with the study medications, procedures, or compromise subject safety. - Unwillingness to abstain from ingestion of any food or drink containing grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos within 7 days prior to the first dose of study treatment(s) or until the end of the study. - Participation in another concurrent clinical study or prior clinical study (with the exception of imaging trials) 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 investigational product (whichever is longer). - Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within 56 days. - Presence of hepatitis B surface antigen (HBsAg), or 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 screen. - A positive test for a diagnostic HIV-1 polymerase chain reaction (PCR). - Exposure to more than four new chemical entities within 12 months prior to the first dosing day. - Exclusion criteria for screening ECG: Heart rate <45 or >100 beats per minute (bpm) for males and <50 or >100 bpm for females; PR interval <120 or >220 millisecond (msec); QRS duration <70 or >120 msec; the Fridericia's QT correction formula (QTcF) interval >450 msec. - Evidence of previous myocardial infarction (does not include ST segment changes associated with re-polarization). - Any conduction abnormality (including but not specific to left or right complete bundle branch block, Atrioventricular block [2nd degree or higher], Wolff-Parkinson-White [WPW] syndrome). - Sinus Pauses >3 seconds. - Any significant arrhythmia which, in the opinion of the Investigator or GlaxoSmithKline/ViiV medical monitor, will interfere with the safety for the individual subject. - Non-sustained or sustained ventricular tachycardia (3 consecutive ventricular ectopic beats). - History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 units. One unit is equivalent to 8 gram of alcohol: a half-pint approximately 240 mL of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits. - Regular use of tobacco- or nicotine-containing products within 3 months prior to screening. - 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.","interventions":[{"arm_group_label":"GSK3640254 receivers (cohort 3-6 and expansion): Part 2","intervention_description":"GSK3640254 is a capsule available in 1 milligram (mg), 10 mg and 100 mg dosing strength. GSK3640254 capsule will be given via oral route during each dosing day with approximately 240 mL of water.","intervention_name":"GSK3640254","intervention_type":"Drug"},{"arm_group_label":"Subjects in cohort 1-2: Part 1","intervention_description":"GSK3640254 is a capsule available in 1 milligram (mg), 10 mg and 100 mg dosing strength. GSK3640254 capsule will be given via oral route during each dosing day with approximately 240 mL of water.","intervention_name":"GSK3640254","intervention_type":"Drug"},{"arm_group_label":"Subjects receiving placebo (cohort 3-6): Part 2","intervention_description":"Placebo capsule matching to the study treatment will be given via oral route during each dosing day with approximately 240 mL of water.","intervention_name":"Placebo","intervention_type":"Drug"},{"arm_group_label":"Subjects in cohort 1-2: Part 1","intervention_description":"Placebo capsule matching to the study treatment will be given via oral route during each dosing day with approximately 240 mL of water.","intervention_name":"Placebo","intervention_type":"Drug"}],"interventional_subtype":"Treatment","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["FTIH","Healthy","Tolerability","Dose-escalation","HIV-1","Safety","PK","GSK3640254","Maturation inhibitor"],"last_follow_up_date":"06/25/2018 00:00:00","links":[],"locations":[{"City":"Cambridge","Latitude":"52.205337","CountryDisplay":"United Kingdom","Longitude":"0.121817","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"CB2 2GG","StatusDisplay":"Recruiting","StatusDisplayInternal":"LOCSTATUS_RECRUITING","StatusMapped":"Recruiting"}],"masking":"","maximum_age_raw":"55 years","maximum_age":"55","minimum_age":"18","minimum_age_raw":"18 years","modified_date":"06/18/2024 13:28:39","number_of_arms":"3","observational_design":{"biospecimen_description":"","biospecimen_retention":"","number_of_groups":"","observational_study_design":"","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":""},"official_title":"A Double-Blind (Sponsor Unblinded), Randomized, Placebo-Controlled, Single and Repeated Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK3640254 in Healthy Participants","org_study_id":"207187","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Recruiting - Interventional","oversight_info":{"exported_from_us":"","fda_regulated_device":"No","fda_regulated_drug":"No","ped_postmarket_surv":"","has_dmc":false,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"1","primary_compl_date":"06/25/2018 00:00:00","primary_outcomes":[{"outcome_description":"An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.","outcome_measure":"Number of subjects with adverse events (AEs) and serious AEs (SAEs): Part 1","outcome_time_frame":"Up to Week 14","outcome_safety_issue":null},{"outcome_description":"Serum chemistry, hematology and urine analysis parameters will be evaluated for single dose of GSK3640254","outcome_measure":"Number of subjects with abnormal laboratory findings: Part 1","outcome_time_frame":"Up to Week 14","outcome_safety_issue":null},{"outcome_description":"Vital signs including tympanic temperature, pulse rate, respiratory rate and systolic and diastolic blood pressure will be evaluated for single dose GSK3640254.","outcome_measure":"Number of subjects with abnormal vital sign values: Part 1","outcome_time_frame":"Up to Week 14","outcome_safety_issue":null},{"outcome_description":"12-lead ECGs will be obtained at each time point and number of subjects with abnormal ECG findings will be evaluated for single dose of GSK3640254.","outcome_measure":"Number of subjects with abnormal electrocardiogram (ECG) findings: Part 1","outcome_time_frame":"Up to Week 14","outcome_safety_issue":null},{"outcome_description":"An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.","outcome_measure":"Number of subjects with adverse events (AEs) and serious AEs (SAEs): Part 2","outcome_time_frame":"Up to 4 weeks in each cohort","outcome_safety_issue":null},{"outcome_description":"Serum chemistry, hematology and urine analysis parameters will be evaluated for repeat dose of GSK3640254.","outcome_measure":"Number of subjects with abnormal laboratory findings: Part 2","outcome_time_frame":"Up to 4 weeks in each cohort","outcome_safety_issue":null},{"outcome_description":"Vital signs including tympanic temperature, pulse rate, respiratory rate and systolic and diastolic blood pressure will be evaluated for repeat dose of GSK3640254.","outcome_measure":"Number of subjects with abnormal vital sign values: Part 2","outcome_time_frame":"Up to 4 weeks in each cohort","outcome_safety_issue":null},{"outcome_description":"12-lead ECGs will be obtained at each time point and number of subjects with abnormal ECG findings will be evaluated for repeat dose of GSK3640254.","outcome_measure":"Number of subjects with abnormal ECG findings: Part 2","outcome_time_frame":"Up to 4 weeks in each cohort","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"Blood sample will be collected at given time points to study the Pharmacokinetic (PK) profile of GSK3640254 given as a single dose.","outcome_measure":"Area under the plasma concentration time curve (AUC) from zero to 24 hour (AUC[0-24]) of GSK3640254: Part 1","outcome_time_frame":"Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,48,72 and 96 hours post-dose in each treatment period for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given as a single dose.","outcome_measure":"AUC from zero to time of last sample taken (AUC[0-Tlast]) of GSK3640254: Part 1","outcome_time_frame":"Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,48,72 and 96 hours post-dose in each treatment period for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given as a single dose.","outcome_measure":"AUC from time zero (pre-dose) extrapolated to infinite time (AUC[0-inf]) of GSK3640254: Part 1","outcome_time_frame":"Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,48,72 and 96 hours post-dose in each treatment period for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given as a single dose.","outcome_measure":"Maximum observed concentration (Cmax) of GSK3640254: Part 1","outcome_time_frame":"Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,48,72 and 96 hours post-dose in each treatment period for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given as a single dose.","outcome_measure":"Concentration of GSK3640254 at 24 hours (C24): Part 1","outcome_time_frame":"24 hours post-dose in each treatment period for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given as a single dose.","outcome_measure":"Time of occurrence of Cmax (Tmax) of GSK3640254: Part 1","outcome_time_frame":"Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,48,72 and 96 hours post-dose in each treatment period for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given as a single dose.","outcome_measure":"Lag time (Tlag) of GSK3640254: Part 1","outcome_time_frame":"Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,48,72 and 96 hours post-dose in each treatment period for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given as a single dose.","outcome_measure":"Apparent terminal phase half-life (T1/2) of GSK3640254: Part 1","outcome_time_frame":"Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,48,72 and 96 hours post-dose in each treatment period for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given as a single dose.","outcome_measure":"Last measurable concentration (Clast) of GSK3640254: Part 1","outcome_time_frame":"Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,48,72 and 96 hours post-dose in each treatment period for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given as a single dose.","outcome_measure":"Time to reach Clast (Tlast) of GSK3640254: Part 1","outcome_time_frame":"Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,48,72 and 96 hours post-dose in each treatment period for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given as a single dose.","outcome_measure":"Apparent oral clearance (CL/F) of GSK3640254: Part 1","outcome_time_frame":"Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,48,72 and 96 hours post-dose in each treatment period for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given on Day 1.","outcome_measure":"AUC(0-24) of GSK3640254: Part 2 Day 1","outcome_time_frame":"Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12 and 24 hours post-dose on Day 1 for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given on Day 1.","outcome_measure":"Cmax of GSK3640254: Part 2 Day 1","outcome_time_frame":"Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12 and 24 hours post-dose on Day 1 for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given on Day 1.","outcome_measure":"C24 of GSK3640254: Part 2 Day 1","outcome_time_frame":"24 hours post-dose on Day 1 for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given on Day 1.","outcome_measure":"Tmax of GSK3640254: Part 2 Day 1","outcome_time_frame":"Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12 and 24 hours post-dose on Day 1 for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given on Day 1.","outcome_measure":"Tlag of GSK3640254: Part 2 Day 1","outcome_time_frame":"Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12 and 24 hours post-dose on Day 1 for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given as repeat dose.","outcome_measure":"AUC from pre-dose to the end of the dosing interval at steady state (AUC[0-tau): Part 2 Day 14","outcome_time_frame":"Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given as repeat dose.","outcome_measure":"Cmax of GSK3640254: Part 2 Day 14","outcome_time_frame":"Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given as repeat dose.","outcome_measure":"Plasma trough concentration (Ctau) of GSK3640254: Part 2 Day 14","outcome_time_frame":"Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given as repeat dose.","outcome_measure":"Tmax of GSK3640254: Part 2 Day 14","outcome_time_frame":"Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given as repeat dose.","outcome_measure":"T1/2 of GSK3640254: Part 2 Day 14","outcome_time_frame":"Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose for each cohort","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected at given time points to study the PK profile of GSK3640254 given as repeat dose.","outcome_measure":"Cl/F of GSK3640254: Part 2 Day 14","outcome_time_frame":"Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose for each cohort","outcome_safety_issue":null},{"outcome_description":"Accumulation will be evaluated for each treatment by determining the ratio of Day 14 (Part 2) to Day 1 for AUC (0-tau).","outcome_measure":"Accumulation ratio of AUC(0-tau) (R [AUC{0-TAU}]): Part 2","outcome_time_frame":"Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 14 for each co","outcome_safety_issue":null},{"outcome_description":"Accumulation will be evaluated for each treatment by determining the ratio of Day 14 (Part 2) to Day 1 for Cmax","outcome_measure":"Accumulation ratio of Cmax (R [CMAX]): Part 2","outcome_time_frame":"Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 14 for each cohort","outcome_safety_issue":null},{"outcome_description":"Accumulation will be evaluated for each treatment by determining the ratio of Day 14 (Part 2) to Day 1 for C(tau)","outcome_measure":"Accumulation ratio of C(tau) (R[CTAU]): Part 2","outcome_time_frame":"Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 14 for each cohort","outcome_safety_issue":null},{"outcome_description":"Attainment of steady-state will be assessed by estimating the slope of pre-dose concentrations for GSK3640254 on Days 2-14 (Part 2)","outcome_measure":"Pre-dose concentration of GSK3640254: Part 2","outcome_time_frame":"Pre-dose on Days 2,3,4,6,8,10,12 and 14 for each cohort","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["GlaxoSmithKline"]},"start_date":"09/19/2017 00:00:00","study_type":"Interventional","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":null}},"pageContext":{"studyId":"207187"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}