Drug Interaction & Methadone & Buprenorphine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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IND number: 101,943

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

Conditions

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Hepatitis C

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Methadone

Intervention Type DRUG

DCV 3DAA FDC

Intervention Type DRUG

BMS-791325

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

DCV 3DAA FDC

Intervention Type DRUG

BMS-791325

Intervention Type DRUG

Buprenorphine

Intervention Type DRUG

Naloxone

Intervention Type DRUG

Interventions

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Methadone

Intervention Type DRUG

DCV 3DAA FDC

Intervention Type DRUG

BMS-791325

Intervention Type DRUG

Buprenorphine

Intervention Type DRUG

Naloxone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes