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

NCT07049939 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-02-25

No results posted yet for this study

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

Interventions

DRUG

Bomedemstat

Capsule for oral administration

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2026-02-17
Completion
2026-02-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07049939 on ClinicalTrials.gov