NCT04568603

Islatravir and Methadone Pharmacokinetics (MK-8591-029)

A Clinical Trial to Study the Effect of a Single Dose of Islatravir (MK-8591) on the Pharmacokinetics of Methadone

• 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

The present study is designed to determine the effect of islatravir (ISL) \[MK-8591\] on methadone pharmacokinetics (PK). The primary objective is to assess whether ISL impacts the area under the plasma concentration time curve from dosing to 24 hours postdose (AUC0-24) of S-methadone and R-methadone in participants on oral methadone therapy. It is hypothesized that the plasma AUC0-24hr for S- and R-methadone will be similar after methadone alone compared to methadone and ISL 60 mg coadministration.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	Islatravir	ISL 30 mg x 2 (60 mg total) capsules taken by mouth.

Timeline

• Start date: 2020-10-16
• Primary completion: 2021-07-09
• Completion: 2021-07-09
• First posted: 2020-09-29
• Last updated: 2025-01-28
• Results posted: 2023-12-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study