At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 17 enrolled
Drug / intervention
Belzutifandrug
Likely dose
Belzutifan 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Single-Dose Study to Investigate the Influence of Hepatic Impairment on the Pharmacokinetics of MK-6482
In Brief
A Phase 1 clinical trial evaluating Belzutifan for Moderate Hepatic Impairment. Completed, enrolled 17 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsModerate Hepatic Impairment
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedAug 2021
Enrollment StartJun 2022
Primary CompletionDec 2023
Study CompletionJan 2024
TodayJul 2026
First PostedAug 9, 2021
Enrollment StartJun 24, 2022
Primary CompletionDec 25, 2023
Study CompletionJan 3, 2024
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.9 years ago
Interventions
Belzutifandrug
Two 40 mg tablets given as a single oral 80 mg dose.