A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015)

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-19

Study Completion Date

2026-02-04

Brief Summary

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The purpose of this study is to learn what happens to MK-8527 in a person's body over time (a pharmacokinetic \[PK\] study). Researchers will compare what happens to MK-8527 in the body when it is given to healthy participants and participants with mild and moderate hepatic (liver) impairment.

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Detailed Description

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Conditions

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Hepatic Impairment Healthy Participants

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Mild Hepatic Impairment (Group 1)

All participants will receive a single dose of MK-8527 on Day 1.

Group Type EXPERIMENTAL

MK-8527

Intervention Type DRUG

Oral administration

Moderate Hepatic Impairment (Group 2)

All participants will receive a single dose of MK-8527 on Day 1.

Group Type EXPERIMENTAL

MK-8527

Intervention Type DRUG

Oral administration

Healthy (Group 3)

All participants will receive a single dose of MK-8527 on Day 1.

Group Type EXPERIMENTAL

MK-8527

Intervention Type DRUG

Oral administration

Interventions

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MK-8527

Oral administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

All participants:

* Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing
* Has body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m\^2

Participants with Mild HI (Group 1) and Moderate HI (Group 2):

* Has mild or moderate hepatic impairment
* Has a diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology
* Is generally in good health with the exception of HI

Healthy Control Participants (Group 3):

\- Healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs

Exclusion Criteria

All participants:

* Has a history of cancer (malignancy)
* Has positive results for human immunodeficiency virus (HIV)
* Has had major surgery and/or donated or lost significant volume of blood within 56 days prior to dosing

Participants with Mild HI (Group 1) and Moderate HI (Group 2):

* With the exception of HI, has a history or presence of clinically significant medical or psychiatric condition or disease
* Is positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb)
* Is positive for Hepatitis C Virus (HCV)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes