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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Renal Impairment; End Stage Renal Disease

Treatments: Drug: Belzutifan

Study type: Interventional

Funder types: Industry

Identifiers

NCT04994522

6482-021

MK-6482-021 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Belzutifan in Participants with ESRD

Experimental group

Description:

In period 1, participants with ESRD will receive a single, oral dose of belzutifan 120 mg on Day 1 after HD. In period 2, participants with ESRD will receive a single, oral dose of belzutifan 120 mg on Day 1 before HD. Each period is 4 days.

Treatment:

Drug: Belzutifan

Belzutifan in Healthy Participants

Experimental group

Description:

In period 1, healthy participants will receive a single, oral dose of belzutifan 120 mg on Day 1 of a 4-day period.

Treatment:

Drug: Belzutifan