NCT04995484

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

An Open-Label, Single-Dose Study to Investigate the Influence of Hepatic Impairment on the Pharmacokinetics of MK-6482

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Moderate Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Belzutifan	Two 40 mg tablets given as a single oral 80 mg dose.

Timeline

• Start date: 2022-06-24
• Primary completion: 2023-12-25
• Completion: 2024-01-03
• First posted: 2021-08-09
• Last updated: 2025-01-13
• Results posted: 2025-01-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study