Drug Interaction & Methadone & Buprenorphine

June 16, 2014 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

IND number: 101,943

Primary purpose: Other: Phase 1 Clinical Pharmacology drug interaction study in healthy subjects

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials Llc
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • CRI Lifetree
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Lifetree Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: DCV 3DAA FDC
Drug: BMS-791325
Drug: Methadone
Active Comparator: 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
Drug: Buprenorphine
Drug: DCV 3DAA FDC
Drug: BMS-791325
Drug: Naloxone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed concentration (Cmax) of R-Methadone for Part 1
Time Frame: 24 timepoints up to Day 13
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
24 timepoints up to Day 13
Cmax of Buprenorphine and Norbuprenorphine for Part 2
Time Frame: 24 timepoints up to Day 13
24 timepoints up to Day 13
AUC(TAU) of Buprenorphine and Norbuprenorphine for Part 2
Time Frame: 24 timepoints up to Day 13
24 timepoints up to Day 13

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

January 21, 2014

First Submitted That Met QC Criteria

January 24, 2014

First Posted (Estimate)

January 27, 2014

Study Record Updates

Last Update Posted (Estimate)

June 17, 2014

Last Update Submitted That Met QC Criteria

June 16, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI443-108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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