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NCT04995484 · ClinicalTrials.gov registry record · Phase 1

A Study of Belzutifan (MK-6482) in Participants With Hepatic Impairment (MK-6482-020)

A Phase 1 study of Moderate Hepatic Impairment, sponsored by Merck Sharp & Dohme.

Completed
Registry status
Phase 1
Development phase
17
Enrollment target
2
Study locations

NCT04995484: Completed Phase 1 study of Moderate Hepatic Impairment, sponsored by Merck Sharp & Dohme.

NCT04995484 is a Phase 1 study of Moderate Hepatic Impairment that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 17 participants, below the 21-participant average among 4 other Moderate Hepatic Impairment trials with a reported enrollment target (19% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04995484, a Phase 1 study of Moderate Hepatic Impairment, has completed, sponsored by Merck Sharp & Dohme.

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

Study Summary

The primary purpose of this study is to compare the plasma pharmacokinetics (PK) of belzutifan (MK-6482) following a single oral 80 mg dose of belzutifan in participants with moderate hepatic impairment to that of healthy matched control participants. This study will also evaluate the safety and tolerability of a single oral 80 mg dose of belzutifan in participants with moderate hepatic impairment.

Primary Outcome

AUC0-Inf was defined as the area under the concentration-time curve of belzutifan from time zero to infinity. Blood samples collected predose and at multiple timepoints postdose were used to determine AUC0-Inf of belzutifan.

Conditions Studied

Moderate Hepatic Impairment

Interventions

  • DRUG Belzutifan

Study Locations (2)

Florida

  • Orlando Clinical Research Center ( Site 0001) - Orlando

Texas

  • The Texas Liver Institute ( Site 0002) - San Antonio

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2022-06-24
Est. Completion 2024-01-03
Phase Phase 1
Merck Sharp & Dohme

558 total trials

What the finished NCT04995484 record still lists

NCT04995484 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 21-participant average among 4 other Moderate Hepatic Impairment trials with a reported enrollment target (19% lower).

The record links to 1 condition, with Moderate Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which Belzutifan is the first listed.

NCT04995484 reports a single indexed study location in Florida, Texas.

Frequently Asked Questions

What is clinical trial NCT04995484 about?

NCT04995484 is a clinical study titled "A Study of Belzutifan (MK-6482) in Participants With Hepatic Impairment (MK-6482-020)". The primary purpose of this study is to compare the plasma pharmacokinetics (PK) of belzutifan (MK-6482) following a single oral 80 mg dose of belzutifan in participants with moderate hepatic impairment to that of healthy matched control participants. This study will also evaluate the safety and tol...

What is the current status of trial NCT04995484?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2022-06-24. Estimated completion is 2024-01-03.

What conditions does trial NCT04995484 study?

This clinical trial studies the following conditions: Moderate Hepatic Impairment.

What interventions are being tested in trial NCT04995484?

The interventions under investigation include: Belzutifan (DRUG).

Who is sponsoring clinical trial NCT04995484?

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

Where is trial NCT04995484 being conducted?

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

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Related registry views

Source: ClinicalTrials.gov NCT04995484, the US trial registry maintained by the National Library of Medicine. NCT04995484 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.