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

NCT07049939 | Completed Phase 1 FDA Drug

• 2 other identifiers: 3543-023MK-3543-023
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Hepatic Insufficiency

Outcome Measures

Primary Outcomes (4)

• Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Bomedemstat in Participants with Mild Hepatic Impairment (HI)

  Blood samples collected to determine the AUC0-inf of bomedemstat.

  Up to 216 hours

• Maximum Plasma Concentration (Cmax) of Bomedemstat in Participants with Mild HI

  Blood samples collected to determine the Cmax of bomedemstat.

  Up to 216 hours

• AUC0-Inf of Bomedemstat in Participants with Moderate HI

  Blood samples collected to determine the AUC0-inf of bomedemstat.

  Up to 216 hours

• Cmax of Bomedemstat in Participants with Moderate HI

  Blood samples collected to determine the Cmax of bomedemstat.

  Up to 216 hours

Secondary Outcomes (16)

• Number of Participants Who Experience an Adverse Event (AE)

  Up to 14 days

• Number of Participants Who Discontinue Study Due to an AE

  Up to 14 days

• Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Bomedemstat in Participants with Mild HI

  Up to 216 hours

• Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Bomedemstat in Participants with Mild HI

  At designated timepoints up to 24 hours postdose

• Plasma Concentration at 24 Hours (C24) of Bomedemstat in Participants with Mild HI

  At designated timepoints up to 24 hours postdose

Study Arms (3)

Mild Hepatic Impairment

EXPERIMENTAL

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

Drug: Bomedemstat

Moderate Hepatic Impairment

EXPERIMENTAL

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

Drug: Bomedemstat

Healthy Matched Control

EXPERIMENTAL

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

Drug: Bomedemstat

Interventions

Bomedemstat DRUG

Capsule for oral administration

Also known as: MK-3543

Healthy Matched Control; Mild Hepatic Impairment; Moderate Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (3)

University of Miami ( Site 0003)

Miami, Florida, 33136, United States

Location

Orlando Clinical Research Center ( Site 0001)

Orlando, Florida, 32809, United States

Location

The Texas Liver Institute ( Site 0002)

San Antonio, Texas, 78215, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

bomedemstat

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: August 20, 2025
• Primary Completion: February 17, 2026
• Study Completion: February 17, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (3)