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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-12

Study Completion Date

2024-04-11

Brief Summary

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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.

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Detailed Description

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Conditions

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End Stage Renal Disease Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Belzutifan in Participants with ESRD

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.

Group Type EXPERIMENTAL

Belzutifan

Intervention Type DRUG

Three 40 mg tablets given as a single oral 120 mg dose.

Belzutifan in Healthy Participants

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

Group Type EXPERIMENTAL

Belzutifan

Intervention Type DRUG

Three 40 mg tablets given as a single oral 120 mg dose.

Interventions

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Belzutifan

Three 40 mg tablets given as a single oral 120 mg dose.

Intervention Type DRUG

Other Intervention Names

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MK-6482 PT2977 WELIREG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes