CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 14 enrolled
Drug / intervention
Islatravirdrug
Likely dose
Islatravir 30 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/NCT04568603
NCT04568603Phase 1Completed
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A Clinical Trial to Study the Effect of a Single Dose of Islatravir (MK-8591) on the Pharmacokinetics of Methadone

Merck Sharp & Dohme LLC·interventional·Posted Sep 29, 2020·Updated Jan 28, 2025

In Brief

A Phase 1 clinical trial evaluating Islatravir for HIV-1 Infection. Completed, enrolled 14 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedSep 29, 2020
Enrollment StartOct 16, 2020
Primary CompletionJul 9, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.8 years ago

Interventions

Islatravirdrug

ISL 30 mg x 2 (60 mg total) capsules taken by mouth.