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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-07

Study Completion Date

2025-11-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy 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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Panel A: Severe RI

Participants with severe RI will be administered a single oral dose of MK-1084 on Day 1 under fasting conditions.

Group Type EXPERIMENTAL

MK-1084

Intervention Type DRUG

Oral tablet

Panel B: Moderate RI

Participants with moderate RI will be administered a single oral dose of MK-1084 on Day 1 under fasting conditions.

Group Type EXPERIMENTAL

MK-1084

Intervention Type DRUG

Oral tablet

Panel C: Healthy

Healthy participants will be administered a single oral dose of MK-1084 on Day 1 under fasting conditions.

Group Type EXPERIMENTAL

MK-1084

Intervention Type DRUG

Oral tablet

Interventions

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MK-1084

Oral tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

All participants:

\- Has a BMI ≥18.0 and ≤40.0 kg/m\^2

Participants with severe or moderate RI:

* 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

Participants with normal renal function:

\- Is medically healthy

Exclusion Criteria

All participants:

* 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

Participants with severe or moderate RI:

* Has a history or presence of renal artery stenosis
* Has a renal transplant or nephrectomy

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes