Phase 1
Completed N=14
A Study of Belzutifan (MK-6482) in Participants With Renal Impairment (MK-6482-021)
Source: ClinicalTrials.gov NCT04994522 ↗Enrolled (actual)
14
Serious AEs
4.8%
Results posted
Apr 2025
Primary outcomePrimary: Area Under the Plasma Concentration Time Curve of Belzutifan From Hour 0 to Infinity (AUC0-inf) — 17100; 21100; 18500 ng•hr/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration Time Curve of Belzutifan From Hour 0 to Infinity (AUC0-inf) |
17100; 21100; 18500 | — |
| PRIMARY Area Under the Plasma Concentration Time Curve of Belzutifan From Hour 0 to 24 (AUC0-24) |
10700; 12300; 13200 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Belzutifan |
1110; 907; 1300 | — |
| PRIMARY Time to Maximum Plasma Concentration (Tmax) of Belzutifan |
2.00; 4.00; 1.00 | — |
| PRIMARY Apparent Terminal Half-life (t½) of Plasma Belzutifan |
15.1; 17.1; 13.9 | — |
| SECONDARY Dialysis Clearance of Belzutifan Based on Plasma (CLD, Plasma) |
78.4 | — |
| SECONDARY Percentage of Participants Who Experienced an Adverse Event (AE) |
14.3; 0.0; 16.7 | — |
| SECONDARY Percentage of Participants Who Discontinue Study Intervention Due to an AE |
0.0; 0.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
For Participants With Healthy Renal Function
- 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).
- 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 a history of cancer (malignancy).
- Has required frequent emergent HD (≥3) within a year prior to the initial dose of study intervention.
- Is positive for HBsAg, hepatitis C antibodies, or HIV.
- 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)
Data sourced from ClinicalTrials.gov (NCT04994522). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.