{"componentChunkName":"component---src-templates-study-details-page-js","path":"/en/study/206281","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":"NCT02063360","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":"Randomized","arm_groups":[{"arm_group_label":"Cohort 1: BMS-663068+DRV/RTV","arm_group_description":"Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet DRV 600mg / RTV 100mg orally orally twice daily on days 7-16","arm_type":"Experimental"},{"arm_group_label":"Cohort 2: BMS-663068+ETR","arm_group_description":"Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet ETR 200mg orally orally twice daily on days 7-16","arm_type":"Experimental"},{"arm_group_label":"Cohort 3: BMS-663068+DRV/RTV+ETR","arm_group_description":"Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet DRV 600mg / RTV 100mg and ETR 200mg orally orally twice daily on days 7-16","arm_type":"Experimental"}],"assignment":"Parallel Assignment","brief_summary":"The purpose of this study is to determine if there is an interaction in healthy subjects taking BMS-663068 with Darunavir/Ritonavir and/or Etravirine.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"DDI study of BMS-663068 with Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 17:35:47","criteria":"Inclusion Criteria: - Healthy subjects with no clinically significant deviation from normal in medical history, physical examination findings, 12-lead ECG measurements, and clinical laboratory tests - Women of childbearing potential (WOCBP) allowed. Must be practicing highly effective methods of contraception Exclusion Criteria: - Any significant acute or chronic medical condition - Unable to tolerate oral medications - Inability to be venipunctured and/or tolerate venous access - Current or recent (within 3 months of dosing) gastrointestinal disease - Abnormal liver function test","detailed_description":"Brief title: drug-drug interaction (DDI) Primary Purpose: Other : Phase 1 Clinical Pharmacology drug interaction study in healthy subjects","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":"42","exclusion":"","gender":"All","gender_based":"","gender_description":"","healthy_volunteers":"Yes","id":"f118b6f3-96d1-555f-b830-d56558d16393","internal":{"content":null,"contentDigest":"7e0f155a552436f0258d0d7398f72dd7","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - Healthy subjects with no clinically significant deviation from normal in medical history, physical examination findings, 12-lead ECG measurements, and clinical laboratory tests - Women of childbearing potential (WOCBP) allowed. Must be practicing highly effective methods of contraception Exclusion Criteria: - Any significant acute or chronic medical condition - Unable to tolerate oral medications - Inability to be venipunctured and/or tolerate venous access - Current or recent (within 3 months of dosing) gastrointestinal disease - Abnormal liver function test","interventions":[{"arm_group_label":"Cohort 2: BMS-663068+ETR","intervention_description":"BMS-663068","intervention_name":"BMS-663068","intervention_type":"Drug"},{"arm_group_label":"Cohort 3: BMS-663068+DRV/RTV+ETR","intervention_description":"BMS-663068","intervention_name":"BMS-663068","intervention_type":"Drug"},{"arm_group_label":"Cohort 1: BMS-663068+DRV/RTV","intervention_description":"BMS-663068","intervention_name":"BMS-663068","intervention_type":"Drug"},{"arm_group_label":"Cohort 3: BMS-663068+DRV/RTV+ETR","intervention_description":"Darunavir (DRV)","intervention_name":"Darunavir (DRV)","intervention_type":"Drug"},{"arm_group_label":"Cohort 1: BMS-663068+DRV/RTV","intervention_description":"Darunavir (DRV)","intervention_name":"Darunavir (DRV)","intervention_type":"Drug"},{"arm_group_label":"Cohort 3: BMS-663068+DRV/RTV+ETR","intervention_description":"Ritonavir (RTV)","intervention_name":"Ritonavir (RTV)","intervention_type":"Drug"},{"arm_group_label":"Cohort 1: BMS-663068+DRV/RTV","intervention_description":"Ritonavir (RTV)","intervention_name":"Ritonavir (RTV)","intervention_type":"Drug"},{"arm_group_label":"Cohort 2: BMS-663068+ETR","intervention_description":"Etravirine (ETR)","intervention_name":"Etravirine (ETR)","intervention_type":"Drug"},{"arm_group_label":"Cohort 3: BMS-663068+DRV/RTV+ETR","intervention_description":"Etravirine (ETR)","intervention_name":"Etravirine (ETR)","intervention_type":"Drug"}],"interventional_subtype":"Other","is_fda_regulated":true,"is_high_value":false,"is_ind_study":true,"keywords":[],"last_follow_up_date":"05/13/2014 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"50 years","maximum_age":"50","minimum_age":"18","minimum_age_raw":"18 years","modified_date":"10/01/2018 22:44:53","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":"Open-Label, Single-Sequence Study to Evaluate the Pharmacokinetic Interaction of BMS-663068 with Darunavir/Ritonavir and/or Etravirine in Healthy Subjects","org_study_id":"206281","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":"05/01/2014 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"Maximum observed plasma concentration (Cmax) of BMS-626529","outcome_time_frame":"20 timepoints up to day 26","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) of BMS-626529","outcome_time_frame":"20 timepoints up to day 26","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[{"id":"AI438-020","id_type":"Other Identifier","id_domain":"Bristol-Myers Squibb"}],"secondary_outcomes":[{"outcome_description":"","outcome_measure":"Time of maximum observed plasma concentration (Tmax) for BMS-626529, DRV, RTV, and ETR","outcome_time_frame":"Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Concentration at 12 hours (C12) for BMS-626529, DRV, RTV, and ETR","outcome_time_frame":"Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Trough observed plasma concentration (Ctrough) for BMS-626529, DRV, RTV, and ETR","outcome_time_frame":"Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Cmax for DRV, RTV, and ETR","outcome_time_frame":"24 timepoints up to 26 day","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"AUC(TAU) for DRV, RTV, and ETR","outcome_time_frame":"24 timepoints up to 26 day","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Safety and tolerability endpoints include incidence of adverse event (AEs), serious adverse event (SAEs), AEs leading to discontinuation, deaths, marked laboratory abnormalities, and abnormalities in vital signs, physical examination, and 12-lead ECGs","outcome_time_frame":"Up to day 27","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["GlaxoSmithKline"]},"start_date":"02/01/2014 00:00:00","study_type":"Interventional","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":false}},"pageContext":{"studyId":"206281"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}