NCT04994522

A Study of Belzutifan (MK-6482) in Participants With Renal Impairment (MK-6482-021)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (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 120 mg dose in participants with end stage renal disease (ESRD) before and after hemodialysis (HD) to each other and also to that of healthy matched control participants. This study will also evaluate the safety and tolerability of a single oral 120 mg dose of belzutifan in participants with ESRD and the extent of belzutifan removed by HD.

Conditions

• End Stage Renal Disease
• Renal Impairment

Interventions

Type	Name	Description
DRUG	Belzutifan	Three 40 mg tablets given as a single oral 120 mg dose.

Timeline

• Start date: 2022-07-12
• Primary completion: 2024-04-01
• Completion: 2024-04-11
• First posted: 2021-08-06
• Last updated: 2025-04-06
• Results posted: 2025-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study