NCT07049939

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

An Open-Label, Single-Dose Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of MK-3543

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Bomedemstat	Capsule for oral administration

Timeline

• Start date: 2025-08-20
• Primary completion: 2026-02-17
• Completion: 2026-02-17
• First posted: 2025-07-03
• Last updated: 2026-02-25

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study