Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-01-20 @ 3:38 AM
Study NCT ID:
NCT02063360
Status:
COMPLETED
Last Update Posted:
2017-08-08
First Post:
2014-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DDI Study of BMS-663068 With Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C576364', 'term': 'fostemsavir'}, {'id': 'D000069454', 'term': 'Darunavir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'C451734', 'term': 'etravirine'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2014-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-07', 'studyFirstSubmitDate': '2014-02-13', 'studyFirstSubmitQcDate': '2014-02-13', 'lastUpdatePostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of BMS-626529', 'timeFrame': '20 timepoints up to day 26'}, {'measure': 'Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) of BMS-626529', 'timeFrame': '20 timepoints up to day 26'}], 'secondaryOutcomes': [{'measure': 'Time of maximum observed plasma concentration (Tmax) for BMS-626529, DRV, RTV, and ETR', 'timeFrame': 'Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)'}, {'measure': 'Concentration at 12 hours (C12) for BMS-626529, DRV, RTV, and ETR', 'timeFrame': 'Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)'}, {'measure': 'Trough observed plasma concentration (Ctrough) for BMS-626529, DRV, RTV, and ETR', 'timeFrame': 'Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)'}, {'measure': 'Cmax for DRV, RTV, and ETR', 'timeFrame': '24 timepoints up to 26 day'}, {'measure': 'AUC(TAU) for DRV, RTV, and ETR', 'timeFrame': '24 timepoints up to 26 day'}, {'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', 'timeFrame': 'Up to day 27'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infection, Human Immunodeficiency Virus']}, 'referencesModule': {'references': [{'pmid': '35315687', 'type': 'DERIVED', 'citation': 'Moore K, Thakkar N, Magee M, Sevinsky H, Vakkalagadda B, Lubin S, Llamoso C, Ackerman P. Pharmacokinetics of Temsavir, the Active Moiety of the HIV-1 Attachment Inhibitor Prodrug, Fostemsavir, Coadministered with Cobicistat, Etravirine, Darunavir/Cobicistat, or Darunavir/Ritonavir with or without Etravirine in Healthy Participants. Antimicrob Agents Chemother. 2022 Apr 19;66(4):e0225121. doi: 10.1128/aac.02251-21. Epub 2022 Mar 22.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Brief title: drug-drug interaction (DDI)\n\nPrimary Purpose: Other : Phase 1 Clinical Pharmacology drug interaction study in healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects with no clinically significant deviation from normal in medical history, physical examination findings, 12-lead ECG measurements, and clinical laboratory tests\n* Women of childbearing potential (WOCBP) allowed. Must be practicing highly effective methods of contraception\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical condition\n* Unable to tolerate oral medications\n* Inability to be venipunctured and/or tolerate venous access\n* Current or recent (within 3 months of dosing) gastrointestinal disease\n* Abnormal liver function test'}, 'identificationModule': {'nctId': 'NCT02063360', 'briefTitle': 'DDI Study of BMS-663068 With Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'Open-Label, Single-Sequence Study to Evaluate the Pharmacokinetic Interaction of BMS-663068 With Darunavir/Ritonavir and/or Etravirine in Healthy Subjects', 'orgStudyIdInfo': {'id': '206281'}, 'secondaryIdInfos': [{'id': 'AI438-020', 'type': 'OTHER', 'domain': 'Bristol-Myers Squibb'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: BMS-663068+DRV/RTV', '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', 'interventionNames': ['Drug: BMS-663068', 'Drug: Darunavir (DRV)', 'Drug: Ritonavir (RTV)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: BMS-663068+ETR', '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', 'interventionNames': ['Drug: BMS-663068', 'Drug: Etravirine (ETR)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: BMS-663068+DRV/RTV+ETR', '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', 'interventionNames': ['Drug: BMS-663068', 'Drug: Darunavir (DRV)', 'Drug: Ritonavir (RTV)', 'Drug: Etravirine (ETR)']}], 'interventions': [{'name': 'BMS-663068', 'type': 'DRUG', 'description': 'BMS-663068', 'armGroupLabels': ['Cohort 1: BMS-663068+DRV/RTV', 'Cohort 2: BMS-663068+ETR', 'Cohort 3: BMS-663068+DRV/RTV+ETR']}, {'name': 'Darunavir (DRV)', 'type': 'DRUG', 'otherNames': ['Prezista'], 'description': 'Darunavir (DRV)', 'armGroupLabels': ['Cohort 1: BMS-663068+DRV/RTV', 'Cohort 3: BMS-663068+DRV/RTV+ETR']}, {'name': 'Ritonavir (RTV)', 'type': 'DRUG', 'otherNames': ['Norvir'], 'description': 'Ritonavir (RTV)', 'armGroupLabels': ['Cohort 1: BMS-663068+DRV/RTV', 'Cohort 3: BMS-663068+DRV/RTV+ETR']}, {'name': 'Etravirine (ETR)', 'type': 'DRUG', 'otherNames': ['Intelence'], 'description': 'Etravirine (ETR)', 'armGroupLabels': ['Cohort 2: BMS-663068+ETR', 'Cohort 3: BMS-663068+DRV/RTV+ETR']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ViiV Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}