CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
boceprevir +2 moredrug
Likely dose
boceprevir 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01396005
NCT01396005Phase 1Completed
CompareCT.gov

An Open-Label, One-Period Study in Patients Receiving Methadone or Buprenorphine/Naloxone Maintenance Therapy to Evaluate the Effect of SCH 503034 (Boceprevir) on Either Methadone or Buprenorphine/Naloxone Plasma Concentrations (Protocol No. P08123)

Merck Sharp & Dohme LLC·interventional·Posted Jul 18, 2011·Updated Apr 7, 2017

In Brief

A Phase 1 clinical trial evaluating boceprevir, methadone, and 1 other intervention for Hepatitis C Virus. Completed, enrolled 21 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 18, 2011
Enrollment StartSep 1, 2011
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.0 years ago

Interventions

boceprevirdrug

boceprevir 800 mg (4 x 200 mg capsules), orally, every 8 hours, Day 2 through Day 7

methadonedrug

methadone, 20-150 mg tablets, liquid, or disket, orally, once per day, Day 1 through Day 8

buprenorphine/naloxonedrug

buprenorphine/naloxone 8/2-24/6 mg, tablets, sublingual, once per day, Day 1 through Day 8