Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-02-25 @ 3:34 AM
Study NCT ID:
NCT02045693
Status:
COMPLETED
Last Update Posted:
2014-06-17
First Post:
2014-01-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Interaction & Methadone & Buprenorphine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008691', 'term': 'Methadone'}, {'id': 'C587012', 'term': '8-cyclohexyl-N-((dimethylamino)sulfonyl)-1,1a,2,12b-tetrahydro-11-methoxy-1a-((3-methyl-3,8-diazabicyclo(3.2.1)oct-8-yl)carbonyl)cycloprop(d)indolo(2,1-a)(2)benzazepine-5-carboxamide'}, {'id': 'D002047', 'term': 'Buprenorphine'}, {'id': 'D009270', 'term': 'Naloxone'}], 'ancestors': [{'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-16', 'studyFirstSubmitDate': '2014-01-21', 'studyFirstSubmitQcDate': '2014-01-24', 'lastUpdatePostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed concentration (Cmax) of R-Methadone for Part 1', 'timeFrame': '24 timepoints up to Day 13'}, {'measure': 'Area under the concentration-time curve in one dosing interval (AUC(TAU)) of R-Methadone for Part 1', 'timeFrame': '24 timepoints up to Day 13'}, {'measure': 'Cmax of Buprenorphine and Norbuprenorphine for Part 2', 'timeFrame': '24 timepoints up to Day 13'}, {'measure': 'AUC(TAU) of Buprenorphine and Norbuprenorphine for Part 2', 'timeFrame': '24 timepoints up to Day 13'}], 'secondaryOutcomes': [{'measure': 'Cmax of S-Methadone and Total Methadone for Part 1', 'timeFrame': '24 timepoints up to 13 days'}, {'measure': 'AUC(TAU) of S-Methadone and Total Methadone for Part 1', 'timeFrame': '24 timepoints up to 13 days'}, {'measure': 'Concentration at 24 hours (C24) of S-Methadone, Total Methadone and R-Methadone for Part 1', 'timeFrame': '24 timepoints up to 13 days'}, {'measure': 'Time of maximum observed concentration (Tmax) of S-Methadone, Total Methadone and R-Methadone for Part 1', 'timeFrame': '24 timepoints up to 13 days'}, {'measure': 'C24 of Buprenorphine and Norbuprenorphine for Part 2', 'timeFrame': '24 timepoints up to 13 days'}, {'measure': 'Tmax of Buprenorphine and Norbuprenorphine for Part 2', 'timeFrame': '24 timepoints up to 13 days'}, {'measure': 'Ratio of metabolite AUC(TAU) to parent AUC(TAU) (MR_AUC(TAU)) of Norbuprenorphine to Buprenorphine', 'timeFrame': '24 timepoints up to 13 days'}, {'measure': 'Cmax of of Daclatasvir (DCV) , Asunaprevir (ASV) , BMS-791325, and BMS-794712', 'timeFrame': '10 timepoints on Day 12'}, {'measure': 'AUC(TAU) of DCV, ASV, BMS-791325, and BMS-794712', 'timeFrame': '10 timepoints on Day 12'}, {'measure': 'Concentration at 12 hours (C12) of DCV, ASV, BMS-791325, and BMS-794712', 'timeFrame': '10 timepoints on Day 12'}, {'measure': 'Tmax of DCV, ASV, BMS-791325, and BMS-794712', 'timeFrame': '10 timepoints on Day 12'}, {'measure': 'MR_AUC(TAU) for BMS-794712 to BMS-791325', 'timeFrame': '10 timepoints on Day 12'}, {'measure': 'Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), death and AEs leading to discontinuation', 'timeFrame': 'Up to day 13'}, {'measure': 'Results of vital signs, Electrocardiograms (ECGs), Physical Examinations (PEs) and clinical labs', 'timeFrame': 'Up to day 13'}, {'measure': 'Scores of Clinical Opiate Withdrawal Scale (COWS), Subjective Opiate Withdrawal Scale (SOWS), Objective Opiate Withdrawal Scale (OOWS), and Opiate Overdose Assessment (OOA)', 'timeFrame': 'Up to day 13'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effects of steady state DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of Methadone in subjects with the stable dose of Methadone and on the PK of Buprenorphine in subjects with the stable dose of Buprenorphine.', 'detailedDescription': 'IND number: 101,943\n\nPrimary purpose: Other: Phase 1 Clinical Pharmacology drug interaction study in healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Subject must be on stable Methadone or Buprenorphine regimens for at least 28 days prior to screening\n\nExclusion Criteria:\n\n* Subjects must be healthy except for history of Methadone or Buprenorphine treatment regimens\n* Prior exposure to DCV, ASV or BMS-791325 within 3 months of screening or any other investigational drug or placebo within 4 weeks of study drug administration'}, 'identificationModule': {'nctId': 'NCT02045693', 'briefTitle': 'Drug Interaction & Methadone & Buprenorphine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase1, Open-Label, Drug-Drug Interaction Study Between Methadone and Daclatasvir/Asunaprevir/BMS-791325 3 DAA FDC + 75mg BMS-791325 and Between Buprenorphine/Naloxone and Daclatasvir/Asunaprevir/BMS-791325 3 DAA FDC +75mg BMS-791325', 'orgStudyIdInfo': {'id': 'AI443-108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Methadone + DCV 3DAA FDC + BMS-791325', 'description': 'Methadone 40-120 mg tablet or solution orally once on Day 1\n\nMethadone 40-120 mg tablet or solution orally once daily + DCV 3DAA FDC (Daclatasvir 30 mg/Asunaprevir 200 mg/BMS-791325 75 mg 3 direct-acting antiviral (3DAA) fixed dose combination tablet) orally twice daily + BMS-791325 75 mg tablet orally twice daily on Days 2 through 12', 'interventionNames': ['Drug: Methadone', 'Drug: DCV 3DAA FDC', 'Drug: BMS-791325']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325', 'description': 'Buprenorphine/Naloxone 8/2 - 24/6 mg tablet or sublingual film orally once on Day 1\n\nBuprenorphine/Naloxone 8/2 - 24/6 mg tablet or sublingual film orally once + DCV 3DAA FDC (Daclatasvir 30 mg/Asunaprevir 200 mg/BMS-791325 75 mg 3DAA fixed dose combination tablet) orally twice daily + BMS-791325 75 mg tablet orally twice daily on Days 2 through 12', 'interventionNames': ['Drug: DCV 3DAA FDC', 'Drug: BMS-791325', 'Drug: Buprenorphine', 'Drug: Naloxone']}], 'interventions': [{'name': 'Methadone', 'type': 'DRUG', 'armGroupLabels': ['Part 1: Methadone + DCV 3DAA FDC + BMS-791325']}, {'name': 'DCV 3DAA FDC', 'type': 'DRUG', 'armGroupLabels': ['Part 1: Methadone + DCV 3DAA FDC + BMS-791325', 'Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325']}, {'name': 'BMS-791325', 'type': 'DRUG', 'armGroupLabels': ['Part 1: Methadone + DCV 3DAA FDC + BMS-791325', 'Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325']}, {'name': 'Buprenorphine', 'type': 'DRUG', 'armGroupLabels': ['Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325']}, {'name': 'Naloxone', 'type': 'DRUG', 'armGroupLabels': ['Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials Llc', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '19139', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Cri Lifetree', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Lifetree Clinical Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}