Drug Interaction & Methadone & Buprenorphine

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: DCV 3DAA FDC; Drug: Methadone; Drug: Buprenorphine; Drug: BMS-791325; Drug: Naloxone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02045693

AI443-108

Details and patient eligibility

About

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.

Full description

IND number: 101,943

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

32 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Methadone

Drug: DCV 3DAA FDC

Drug: BMS-791325

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

Active Comparator group

Description:

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

Treatment:

Drug: Naloxone

Drug: DCV 3DAA FDC

Drug: Buprenorphine

Drug: BMS-791325