Clinical Trials/NCT02045693

NCT02045693

Completed

Phase 1

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

Bristol-Myers Squibb3 sites in 1 country32 target enrollmentFebruary 2014

ConditionsHepatitis C

InterventionsMethadone DCV 3DAA FDC BMS-791325 Buprenorphine Naloxone

DrugsMethadone DCV 3DAA FDC BMS-791325 Buprenorphine Naloxone

Overview

Phase: Phase 1
Intervention: Methadone
Conditions: Hepatitis C
Sponsor: Bristol-Myers Squibb
Enrollment: 32
Locations: 3
Primary Endpoint: Maximum observed concentration (Cmax) of R-Methadone for Part 1
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

IND number: 101,943 Primary purpose: Other: Phase 1 Clinical Pharmacology drug interaction study in healthy subjects

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

April 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must be on stable Methadone or Buprenorphine regimens for at least 28 days prior to screening

Exclusion Criteria

•Subjects must be healthy except for history of Methadone or Buprenorphine treatment regimens
•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

Arms & Interventions

Part 1: Methadone + DCV 3DAA FDC + BMS-791325

Methadone 40-120 mg tablet or solution orally once on Day 1 Methadone 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

Intervention: Methadone

Part 1: Methadone + DCV 3DAA FDC + BMS-791325

Intervention: DCV 3DAA FDC

Part 1: Methadone + DCV 3DAA FDC + BMS-791325

Intervention: BMS-791325

Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325

Buprenorphine/Naloxone 8/2 - 24/6 mg tablet or sublingual film orally once on Day 1 Buprenorphine/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

Intervention: DCV 3DAA FDC

Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325

Intervention: BMS-791325

Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325

Intervention: Buprenorphine

Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325

Intervention: Naloxone

Outcomes

Primary Outcomes

Maximum observed concentration (Cmax) of R-Methadone for Part 1

Time Frame: 24 timepoints up to Day 13

Area under the concentration-time curve in one dosing interval (AUC(TAU)) of R-Methadone for Part 1

Time Frame: 24 timepoints up to Day 13

Cmax of Buprenorphine and Norbuprenorphine for Part 2

Time Frame: 24 timepoints up to Day 13

AUC(TAU) of Buprenorphine and Norbuprenorphine for Part 2

Time Frame: 24 timepoints up to Day 13

Secondary Outcomes

AUC(TAU) of DCV, ASV, BMS-791325, and BMS-794712(10 timepoints on Day 12)
Concentration at 12 hours (C12) of DCV, ASV, BMS-791325, and BMS-794712(10 timepoints on Day 12)
Tmax of DCV, ASV, BMS-791325, and BMS-794712(10 timepoints on Day 12)
MR_AUC(TAU) for BMS-794712 to BMS-791325(10 timepoints on Day 12)
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), death and AEs leading to discontinuation(Up to day 13)
Results of vital signs, Electrocardiograms (ECGs), Physical Examinations (PEs) and clinical labs(Up to day 13)
Scores of Clinical Opiate Withdrawal Scale (COWS), Subjective Opiate Withdrawal Scale (SOWS), Objective Opiate Withdrawal Scale (OOWS), and Opiate Overdose Assessment (OOA)(Up to day 13)
Cmax of S-Methadone and Total Methadone for Part 1(24 timepoints up to 13 days)
AUC(TAU) of S-Methadone and Total Methadone for Part 1(24 timepoints up to 13 days)
Concentration at 24 hours (C24) of S-Methadone, Total Methadone and R-Methadone for Part 1(24 timepoints up to 13 days)
Time of maximum observed concentration (Tmax) of S-Methadone, Total Methadone and R-Methadone for Part 1(24 timepoints up to 13 days)
C24 of Buprenorphine and Norbuprenorphine for Part 2(24 timepoints up to 13 days)
Tmax of Buprenorphine and Norbuprenorphine for Part 2(24 timepoints up to 13 days)
Ratio of metabolite AUC(TAU) to parent AUC(TAU) (MR_AUC(TAU)) of Norbuprenorphine to Buprenorphine(24 timepoints up to 13 days)
Cmax of of Daclatasvir (DCV) , Asunaprevir (ASV) , BMS-791325, and BMS-794712(10 timepoints on Day 12)