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NCT04515641 · ClinicalTrials.gov registry record · Phase 1

Single-Dose Islatravir in Moderate Hepatic Impairment (MK-8591-030)

A Phase 1 study, sponsored by Merck Sharp & Dohme.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT04515641 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 12 participants.

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The verdict

NCT04515641, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

This is an open-label, single-dose study of the plasma pharmacokinetics (PK), safety, and tolerability of islatravir (ISL, MK-8591), and the intracellular PK of ISL triphosphate (ISL-TP) in male and female adult participants with moderate hepatic impairment and in healthy matched control participants.

Interventions

  • DRUG Islatravir

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2020-11-05
Est. Completion 2021-09-13
Phase Phase 1

Sponsor

Merck Sharp & Dohme

558 total trials

What the Registry Record Tells You About NCT04515641

The ClinicalTrials.gov registry entry for NCT04515641 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Islatravir is the first listed.

NCT04515641 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04515641 about?

NCT04515641 is a clinical study titled "Single-Dose Islatravir in Moderate Hepatic Impairment (MK-8591-030)". This is an open-label, single-dose study of the plasma pharmacokinetics (PK), safety, and tolerability of islatravir (ISL, MK-8591), and the intracellular PK of ISL triphosphate (ISL-TP) in male and female adult participants with moderate hepatic impairment and in healthy matched control participant...

What is the current status of trial NCT04515641?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2020-11-05. Estimated completion is 2021-09-13.

What interventions are being tested in trial NCT04515641?

The interventions under investigation include: Islatravir (DRUG).

Who is sponsoring clinical trial NCT04515641?

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

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

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.