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NCT04994522 · ClinicalTrials.gov registry record · Phase 1
A Study of Belzutifan (MK-6482) in Participants With Renal Impairment (MK-6482-021)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT04994522: Completed Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT04994522 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04994522, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study 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.
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 in plasma.
Interventions
- DRUG Belzutifan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2022-07-12 |
| Est. Completion | 2024-04-11 |
| Phase | Phase 1 |
What the finished NCT04994522 record still lists
NCT04994522 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Belzutifan is the first listed.
NCT04994522 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04994522 about?
NCT04994522 is a clinical study titled "A Study of Belzutifan (MK-6482) in Participants With Renal Impairment (MK-6482-021)". 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. ...
What is the current status of trial NCT04994522?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2022-07-12. Estimated completion is 2024-04-11.
What interventions are being tested in trial NCT04994522?
The interventions under investigation include: Belzutifan (DRUG).
Who is sponsoring clinical trial NCT04994522?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04994522's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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