A Clinical Study of MK-1084 in Participants With Renal Impairment (MK-1084-010)

Description

The goal of this study is to learn what happens to MK-1084 levels in a person's body over time. Researchers will measure what happens to MK-1084 levels in the body when it is given to people with moderate or severe renal impairment (RI) (meaning the kidneys do not work properly) as compared to people who are in good health. Researchers also want to learn about the safety of MK-1084 when it is given to people with RI and if people with RI can tolerate it.

Conditions

Healthy, Renal Impairment

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Study Overview

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Study Details

Study overview

The goal of this study is to learn what happens to MK-1084 levels in a person's body over time. Researchers will measure what happens to MK-1084 levels in the body when it is given to people with moderate or severe renal impairment (RI) (meaning the kidneys do not work properly) as compared to people who are in good health. Researchers also want to learn about the safety of MK-1084 when it is given to people with RI and if people with RI can tolerate it.

A Clinical Study to Evaluate the Effect of Renal Impairment on the Single-Dose Pharmacokinetics of MK-1084

A Clinical Study of MK-1084 in Participants With Renal Impairment (MK-1084-010)

Condition
Healthy
Intervention / Treatment

-

Contacts and Locations

Orlando

Orlando Clinical Research Center ( Site 0002), Orlando, Florida, United States, 32809

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * With the exception of RI, is sufficiently healthy for study participation
  • * Has stable renal function with no clinically significant change in renal status at least 29 days prior to dosing and is not currently or has not been previously on dialysis for at least 1 year
  • * Has a history of cancer (malignancy)
  • * Has positive results for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus
  • * Has had major surgery and/or donated or lost significant volume of blood within 56 days prior to dosing
  • * Has a history or presence of renal artery stenosis
  • * Has a renal transplant or nephrectomy

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2025-12-04