NCT02715700

Effects of Doravirine (MK-1439) on Methadone Pharmacokinetics in Methadone-Maintained Participants (MK-1439-045)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Human Immunodeficiency Virus (HIV) Infection

Interventions

Type	Name	Description
DRUG	Methadone	Methadone 20 to 200 mg (10 mg/mL if oral solution concentrate) oral tablet once per day.
DRUG	Doravirine	Doravirine 100 mg oral tablet once per day.

Timeline

• Start date: 2015-09-28
• Primary completion: 2016-06-13
• Completion: 2016-08-15
• First posted: 2016-03-22
• Last updated: 2019-06-25
• Results posted: 2019-06-03