NCT04994522CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 6 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 2 Aug 2021
- Start date
- Jul 2022
- Primary completion date
- Apr 2024
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Chronic kidney disease
- NCT number
- NCT04994522
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 14
- From Jul 2022 to the primary completion date, Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
- Has received any non-live vaccine starting from 14 days prior to study intervention or is scheduled to receive any non-live vaccine through 30 days following study intervention (except coronavirus disease 2019 \[COVID-19\]).
- Participants With ESRD
- Has required frequent emergent HD (≥3) within a year prior to the initial dose of study intervention.
- Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
- Has received any non-live vaccine starting from 14 days prior to study intervention or is scheduled to receive any non-live vaccine through 30 days following study intervention (except COVID-19)
Other illness
- Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
- Has a history of cancer (malignancy).
- Is positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV).
- Has a history of cancer (malignancy).
- Is positive for HBsAg, hepatitis C antibodies, or HIV.
Other
- For Participants With Healthy Renal Function
Who the study is looking for
- For Participants With Healthy Renal Function
- Is in good health based on the opinion of the investigator.
- Male participants agree to remain abstinent from heterosexual intercourse on a long-term basis or must agree to use contraception as instructed.
- Female participants must be of nonchildbearing potential.
- For Participants With end stage renal disease (ESRD)
- With exception of the renal impairment, is in good health based on the opinion of the investigator.
- Has ESRD maintained on stable regimen of at least 3 times per week hemodialysis (HD) for at least 3 months prior to the initial administration of the study intervention.
- Male participants agree to remain abstinent from heterosexual intercourse on a long-term basis or must agree to use contraception as instructed.
- Female participants must be of nonchildbearing potential.
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Orlando Clinical Research Center ( Site 0001) Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.