Conditions: Hepatitis C Virus
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 21
Healthy volunteers: no

Brief summary:
In this study, participants on methadone or buprenorphine/naloxone maintenance therapy will be given boceprevir. Blood samples will be taken at specified intervals to find out whether boceprevir affects the pharmacokinetics of methadone, buprenorphine, or naloxone.

Detailed description:

Arms:
arm 1: Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg \[4 x 200 mg capsules\], orally, every 8 hours) on Days 2 through 7) arm 2: Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg \[4 x 200 mg capsules\], orally, every 8 hours) on Days 2 through 7

Interventions: intervention 1: boceprevir intervention 2: methadone intervention 3: buprenorphine/naloxone
Intervention descriptions: intervention 1: boceprevir 800 mg (4 x 200 mg capsules), orally, every 8 hours, Day 2 through Day 7 intervention 2: methadone, 20-150 mg tablets, liquid, or disket, orally, once per day, Day 1 through Day 8 intervention 3: buprenorphine/naloxone 8/2-24/6 mg, tablets, sublingual, once per day, Day 1 through Day 8

Protocol document: