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

April 4, 2024 updated by: Merck Sharp & Dohme LLC

An Open-Label, Single-Dose Study to Investigate the Influence of Renal Impairment on the Pharmacokinetics of MK-6482

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32809
        • Orlando Clinical Research Center ( Site 0001)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 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 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Belzutifan in Participants with ESRD
Participants with ESRD will receive a single dose of belzutifan 120 mg orally on Day 1 of a 4-day treatment period (Period 1), followed by a ≥7 day washout period. Participants receive another single dose of belzutifan 120 mg orally on Day 1 of a 4-day treatment period (Period 2).
Drug: Belzutifan
Three 40 mg tablets given as a single oral 120 mg dose.
Other Names:
  • MK-6482
  • PT2977
  • WELIREG
Experimental: Belzutifan in Healthy Participants
Participants in the healthy matched control group will receive a single dose of belzutifan 120 mg orally on Day 1 of a 4-day treatment period (Period 1).
Drug: Belzutifan
Three 40 mg tablets given as a single oral 120 mg dose.
Other Names:
  • MK-6482
  • PT2977
  • WELIREG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the plasma concentration time curve of belzutifan from hour 0 to infinity (AUC0-inf)
Time Frame: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose
Blood samples collected predose and at multiple timepoints postdose will be used to determine AUC0-inf of belzutifan.
Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose
Area under the plasma concentration time curve of belzutifan from hour 0 to 24 (AUC0-24)
Time Frame: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, and 24 hours postdose
Blood samples collected predose and at multiple timepoints postdose will be used to determine AUC0-24 of belzutifan.
Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, and 24 hours postdose
Maximum plasma concentration (Cmax) of belzutifan
Time Frame: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose
Blood samples collected predose and at multiple timepoints postdose will be used to determine Cmax of belzutifan.
Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose
Time to maximum plasma concentration (Tmax) of belzutifan
Time Frame: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose
Blood samples collected predose and at multiple timepoints postdose will be used to determine Tmax of belzutifan.
Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose
Apparent terminal half-life (t½) of plasma belzutifan
Time Frame: Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose
Blood samples collected predose and at multiple timepoints postdose will be used to determine the apparent terminal t1/2 of belzutifan.
Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dialysis clearance of belzutifan based on plasma (CLD, plasma)
Time Frame: Pre-dialysis, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, and 4 hours post-dialysis on Day 1 of Period 2 (Study Day ~12)
Blood samples collected at pre-dialysis and at multiple timepoints post-dialysis will be used to measure the extent of belzutifan removal by HD.
Pre-dialysis, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, and 4 hours post-dialysis on Day 1 of Period 2 (Study Day ~12)
Number of participants who experienced an adverse event (AE)
Time Frame: Up to approximately 29 days
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experienced an AE will be reported.
Up to approximately 29 days
Number of participants who discontinued from the study due to an AE
Time Frame: Up to approximately 29 days
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinued the study due to an AE will be reported.
Up to approximately 29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2022

Primary Completion (Actual)

April 1, 2024

Study Completion (Estimated)

April 12, 2024

Study Registration Dates

First Submitted

August 2, 2021

First Submitted That Met QC Criteria

August 2, 2021

First Posted (Actual)

August 6, 2021

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6482-021
  • MK-6482-021 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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