At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 14 enrolled

Drug / intervention

Methadone +1 moredrug

Likely dose

Methadone 200 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/NCT02715700

NCT02715700Phase 1Completed

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A Multiple-Dose Clinical Trial to Study the Effect of MK-1439 (Doravirine) on Methadone Pharmacokinetics

Merck Sharp & Dohme LLC·interventional·Posted Mar 22, 2016·Updated Jun 25, 2019

In Brief

A Phase 1 clinical trial evaluating Methadone and Doravirine for Human Immunodeficiency Virus (HIV) Infection. Completed, enrolled 14 participants.

Detailed Summary

This study will evaluate the effects of multiple doses of doravirine (MK-1439) on the pharmacokinetics of methadone in participants requiring methadone maintenance therapy. The primary hypothesis is that area under the plasma concentration-time curve to 24 hours postdose (AUC0-24) of (R)-methadone is similar when a maintenance regimen of methadone is administered with or without multiple daily doses of doravirine.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHuman Immunodeficiency Virus (HIV) Infection

Countries--

Collaborators--

Timeline

Phase 1CompletedFinished

20162017201820192020202120222023202420252026

Enrollment StartSep 2015

First PostedMar 2016

Primary CompletionJun 2016

Study CompletionAug 2016

TodayJul 2026

First PostedMar 22, 2016

Enrollment StartSep 28, 2015

Primary CompletionJun 13, 2016

Study CompletionAug 15, 2016

TodayJul 2, 2026

Enrollment to primary: 9 monthsPosted 10.3 years ago

Interventions

Methadonedrug

Methadone 20 to 200 mg (10 mg/mL if oral solution concentrate) oral tablet once per day.

Doravirinedrug

Doravirine 100 mg oral tablet once per day.