A Study of Bomedemstat (MK-3543) in Participants With Mild or Moderate Hepatic Impairment (MK-3543-023)

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-20

Study Completion Date

2026-03-16

Brief Summary

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The purpose of this study is to learn what happens to bomedemstat (MK-3543) in a person's body over time. Researchers will compare what happens to bomedemstat in the body when it is given to participants with mild or moderate hepatic (liver) impairment and healthy participants.

Participants will be allocated to one of three groups: mild hepatic impairment (HI), moderate HI, or healthy matched control. All participants will receive a single oral dose of bomedemstat on Day 1.

Healthy control participants will be enrolled after hepatic impairment participants have been dosed. Healthy control participants will be matched for the mean age and mean body-mass index (BMI) of all participants with HI (mild and moderate HI combined) and sex to each HI group separately.

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Detailed Description

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Conditions

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Hepatic Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mild Hepatic Impairment

Participants with mild hepatic impairment will receive a single oral 25 mg dose of bomedemstat on Day 1.

Group Type EXPERIMENTAL

Bomedemstat

Intervention Type DRUG

Capsule for oral administration

Moderate Hepatic Impairment

Participants with mild hepatic impairment will receive a single oral 25 mg dose of bomedemstat on Day 1.

Group Type EXPERIMENTAL

Bomedemstat

Intervention Type DRUG

Capsule for oral administration

Healthy Matched Control

Healthy participants will receive a single oral 25 mg dose of bomedemstat on Day 1.

Group Type EXPERIMENTAL

Bomedemstat

Intervention Type DRUG

Capsule for oral administration

Interventions

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Bomedemstat

Capsule for oral administration

Intervention Type DRUG

Other Intervention Names

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MK-3543

Eligibility Criteria

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Inclusion Criteria

* Is a non-smoker or is a moderate smoker for at least 3 months prior to dosing

Participants with Mild and Moderate HI

* Is classified as having either mild HI (Group 1) or moderate HI (Group 2) score on the Child-Pugh scale ranging from 5 to 6 (mild) or 7 to 9 (moderate)
* Has a diagnosis of chronic (\> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology

Healthy Control Participants:

* Must match the mean age (± 15 years) of participants with mild HI and moderate HI
* Must match the mean body-mass index (BMI) (± 25%) of participants with mild HI (Group 1) and moderate HI
* Must match the sex ratio (±2) of participants in each HI group, separately

Exclusion Criteria

All Participants

* History of cancer (malignancy)
* Female participants of childbearing potential
* Is positive for Hepatitis C virus (HCV)
* Is positive for Hepatitis B surface antigen (HBsAg)
* Is positive for human immunodeficiency virus (HIV)

Participants with Mild and Moderate HI

* Has any significant arrhythmia or conduction abnormality
* Severe complications of liver disease within the preceding 3 months
* Primary biliary cholangitis or biliary obstruction
* Has a history of a recent variceal bleeds
* Has evidence of hepatorenal syndrome
* Has a history of liver or other solid organ transplantation
* Has an active infection requiring systemic therapy
* Requires paracentesis more often than 2 times per month
* Has transjugular intrahepatic portosystemic shunt and/or has undergone portacaval shunting

Healthy Control Participants

* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Is a regular user of cannabis products within approximately 6 months of study

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes