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NCT04568603 · ClinicalTrials.gov registry record · Phase 1

Islatravir and Methadone Pharmacokinetics (MK-8591-029)

A Phase 1 study of HIV-1-infection, sponsored by Merck Sharp & Dohme.

Completed
Registry status
Phase 1
Development phase
14
Enrollment target
2
Study locations

NCT04568603 is a Phase 1 study of HIV-1-infection that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 14 participants, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT04568603, a Phase 1 study of HIV-1-infection, has completed, sponsored by Merck Sharp & Dohme.

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target
2
Study locations

Study 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 Studied

HIV-1-infection

Interventions

  • DRUG Islatravir

Study Locations (2)

Florida

  • Research Centers of America, LLC ( Site 0002) - Hollywood

Utah

  • PRA Health Sciences ( Site 0001) - Salt Lake City

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2020-10-16
Est. Completion 2021-07-09
Phase Phase 1

Sponsor

Merck Sharp & Dohme

558 total trials

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What the Registry Record Tells You About NCT04568603

The ClinicalTrials.gov registry entry for NCT04568603 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (96% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 1 intervention - of which Islatravir is the first listed.

NCT04568603 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, Utah.

Frequently Asked Questions

What is clinical trial NCT04568603 about?

NCT04568603 is a clinical study titled "Islatravir and Methadone Pharmacokinetics (MK-8591-029)". 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-methadon...

What is the current status of trial NCT04568603?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2020-10-16. Estimated completion is 2021-07-09.

What conditions does trial NCT04568603 study?

This clinical trial studies the following conditions: HIV-1-infection.

What interventions are being tested in trial NCT04568603?

The interventions under investigation include: Islatravir (DRUG).

Who is sponsoring clinical trial NCT04568603?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04568603 being conducted?

This trial has 2 study locations across Florida, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.