Clinical Trial

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

Completed Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2025-06-25; most recent amendment 2026-02-24.
Status change: Active, Not Recruiting → Completed 2026-02-24
Status change: Recruiting → Active, Not Recruiting 2026-02-02
Status change: Not Yet Recruiting → Recruiting 2025-09-01
Trial Details
NCT Number NCT07049939
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Hepatic Insufficiency
Enrollment 9 participants
Start Date 2025-08-20
Primary Completion 2026-02-17 (estimated)
Study Completion 2026-02-17 (estimated)
Updated on ClinicalTrials.gov 2026-02-25