{"componentChunkName":"component---src-templates-study-details-page-js","path":"/en/study/206278","result":{"data":{"studyNotFoundJson":{"title":"Study not found","content":{"childMarkdownRemark":{"html":"<p>If you entered a web address please check it was correct.</p>\n<p>You can also try <a href=\"/en/studies\">Search Page</a> to find the study you are looking for.</p>"}}},"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":"<p>A unique number for a study given by ViiV.</p>"}},"ctGov":{"childMarkdownRemark":{"html":"<p>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.</p>"}},"eudraCT":{"childMarkdownRemark":{"html":"<p>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.</p>"}}}},"site":{"siteMetadata":{"siteUrl":"https://www.viiv-studyregister.com"}},"studyDetails":{"nct_number":"NCT02480894","ctis_id":"","HasResults":"false","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":"","no_masking":"true"},"PatientLevelData":"false","SharingIpd":"None","acronym":"","allocation":"N/A","arm_groups":[{"arm_group_label":"Sequential Dosing","arm_group_description":"Treatment A: BMS-663068 orally twice daily (BID) on Days 1 through 4 Treatment B: Maraviroc BID on Days 7 through 11 Treatment C: BMS-663068 BID plus maraviroc BID on Days 12 through 18","arm_type":"Experimental"}],"assignment":"Single Group Assignment","brief_summary":"This is a Phase 1, open-label, single sequence, two-way interaction study in healthy male and female subjects. For the effect of maraviroc on the pharmacokinetics (PK) of BMS-626529 (the active moiety of BMS-663068), there is no formal hypothesis to be statistically tested. The purpose of this assessment is to estimate the effect of maraviroc on the PK of BMS-626529 when coadministered in healthy subjects. For the effect of BMS-663068 on the PK of maraviroc, the hypothesis to be statistically tested is that BMS-663068 will not have a clinically significant effect on the PK of maraviroc when coadministered in healthy subjects.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"A Open-label, Drug-Drug Interaction with Maraviroc (DDI)","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 17:34:06","criteria":"Inclusion Criteria: - Healthy male and female nonsmoking subjects ages 18 to 50 years, inclusive with a body mass index of 18.0 to 32.0 kg/m2, inclusive - Women of childbearing potential must agree to follow instructions for methods of contraception for a total of 34 days post-treatment completion Exclusion Criteria: - Any condition possibly affecting drug absorption - Pre-existing liver dysfunction - Any significant acute or chronic medical illness - Orthostatic intolerance - Other protocol specified exclusion criteria could apply","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 1","display_phase_internal":"PHASE_1","display_status":"Completed","display_status_internal":"RECSTATUS_I_COMPLETED","endpoint":"","enrollment":"112","exclusion":"","gender":"All","gender_based":"","gender_description":"","healthy_volunteers":"Yes","id":"e8a058b2-578a-597d-9797-2ff13b6db155","internal":{"content":null,"contentDigest":"b7d82595bd82815badceac1b81f71860","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - Healthy male and female nonsmoking subjects ages 18 to 50 years, inclusive with a body mass index of 18.0 to 32.0 kg/m2, inclusive - Women of childbearing potential must agree to follow instructions for methods of contraception for a total of 34 days post-treatment completion Exclusion Criteria: - Any condition possibly affecting drug absorption - Pre-existing liver dysfunction - Any significant acute or chronic medical illness - Orthostatic intolerance - Other protocol specified exclusion criteria could apply","interventions":[{"arm_group_label":"Sequential Dosing","intervention_description":"BMS-663068","intervention_name":"BMS-663068","intervention_type":"Drug"},{"arm_group_label":"Sequential Dosing","intervention_description":"Maraviroc","intervention_name":"Maraviroc","intervention_type":"Drug"}],"interventional_subtype":"Treatment","is_fda_regulated":true,"is_high_value":false,"is_ind_study":true,"keywords":[],"last_follow_up_date":"09/21/2015 00:00:00","links":[],"locations":[{"City":"San Antonio","Latitude":"29.4854054","CountryDisplay":"United States","Longitude":"-98.4513272","Name":"GSK Investigational Site","StateDisplay":"Texas","PostalCode":"78209","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"}],"masking":"","maximum_age_raw":"50 years","maximum_age":"50","minimum_age":"18","minimum_age_raw":"18 years","modified_date":"10/01/2018 22:44:36","number_of_arms":"1","observational_design":{"biospecimen_description":"","biospecimen_retention":"","number_of_groups":"","observational_study_design":"","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":""},"official_title":"A Phase 1, Open-label, Drug-drug Interaction Study between BMS-663068 and Maraviroc in Healthy Subjects","org_study_id":"206278","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Completed - Interventional","oversight_info":{"exported_from_us":"","fda_regulated_device":"","fda_regulated_drug":"","ped_postmarket_surv":"","has_dmc":false,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"1","primary_compl_date":"09/21/2015 00:00:00","primary_outcomes":[{"outcome_description":"PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include: - Cmax","outcome_measure":"BMS-626529 Pharmacokinetics: maximum observed plasma concentration (Cmax)","outcome_time_frame":"predose and up to 12 hours post dose on Days 4, 16, 17, and 18","outcome_safety_issue":null},{"outcome_description":"PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include: - AUC(TAU)","outcome_measure":"BMS-626529 Pharmacokinetics: area under the plasma concentration-time curve (AUC) in a single dosing interval AUC(TAU)","outcome_time_frame":"predose and up to 12 hours post dose on Days 4, 16, 17, and 18","outcome_safety_issue":null},{"outcome_description":"PK parameters for maraviroc in the absence or presence of BMS-663068 include: - Cmax","outcome_measure":"Maraviroc Pharmacokinetics: Cmax","outcome_time_frame":"predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18","outcome_safety_issue":null},{"outcome_description":"PK parameters for maraviroc in the absence or presence of BMS-663068 include: - AUC(TAU)","outcome_measure":"Maraviroc Pharmacokinetics: AUC(TAU)","outcome_time_frame":"predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[{"id":"AI438-052","id_type":"Other Identifier","id_domain":"Bristol-Myers Squibb"}],"secondary_outcomes":[{"outcome_description":"PK parameters for BMS-626529 include: - Tmax","outcome_measure":"Other PK Parameters for BMS-626529: Time of maximum observed plasma concentration (Tmax)","outcome_time_frame":"predose and up to 12 hours post dose on Days 4, 16, 17, and 18","outcome_safety_issue":null},{"outcome_description":"PK parameters for BMS-626529 include: - C12","outcome_measure":"Other PK Parameters for BMS-626529: plasma concentration observed at 12 hours post-dose (C12)","outcome_time_frame":"predose and up to 12 hours post dose on Days 4, 16, 17, and 18","outcome_safety_issue":null},{"outcome_description":"PK parameters for BMS-626529 include: - Ctrough (predose)","outcome_measure":"Other PK Parameters for BMS-626529: trough observed plasma concentration (Ctrough) (predose)","outcome_time_frame":"predose and up to 12 hours post dose on Days 4, 16, 17, and 18","outcome_safety_issue":null},{"outcome_description":"PK Parameters for maraviroc include: -Tmax","outcome_measure":"Other PK Parameters for maraviroc: Tmax","outcome_time_frame":"predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18","outcome_safety_issue":null},{"outcome_description":"PK Parameters for maraviroc include: -C12","outcome_measure":"Other PK Parameters for maraviroc: C12","outcome_time_frame":"predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18","outcome_safety_issue":null},{"outcome_description":"PK Parameters for maraviroc include: - Ctrough","outcome_measure":"Other PK Parameters for maraviroc: Ctrough","outcome_time_frame":"predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18","outcome_safety_issue":null},{"outcome_description":"Adverse event monitoring","outcome_measure":"Clinical Safety as Measured by Adverse Events","outcome_time_frame":"Day 1 to Day 26","outcome_safety_issue":null},{"outcome_description":"Vital sign measurement","outcome_measure":"Clinical Safety as Measured by Vital Signs","outcome_time_frame":"Day 1 to Day 26","outcome_safety_issue":null},{"outcome_description":"12-lead ECGs","outcome_measure":"Clinical Safety as Measured by Electrocardiograms (ECGs)","outcome_time_frame":"Day 1 to Day 26","outcome_safety_issue":null},{"outcome_description":"Physical examinations","outcome_measure":"Clinical Safety as Measured by Physical Examination","outcome_time_frame":"Day 1 to Day 26","outcome_safety_issue":null},{"outcome_description":"Clinical chemistry, hematology, urinalysis","outcome_measure":"Clinical Safety as Measured by Clinical Laboratory Evaluations","outcome_time_frame":"Day 1 to Day 26","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["GlaxoSmithKline"]},"start_date":"07/07/2015 00:00:00","study_type":"Interventional","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":false}},"pageContext":{"studyId":"206278"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}