Drug Interaction & Methadone & Buprenorphine

Completed · Phase 1

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT02045693

Run by

Bristol-Myers Squibb

People needed

32

Starts

2014-02-01

Expected to finish

2014-04-01

Last updated by the study team

2014-06-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Anaheim Clinical Trials Llc — Anaheim, California, United States
• Cri Lifetree — Philadelphia, Pennsylvania, United States
• Lifetree Clinical Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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