A Study of Bomedemstat (MK-3543) in Participants With Mild or Moderate Hepatic Impairment (MK-354… (NCT07049939) | Clinical Trial Compass
CompletedPhase 1
A Study of Bomedemstat (MK-3543) in Participants With Mild or Moderate Hepatic Impairment (MK-3543-023)
United States9 participantsStarted 2025-08-20
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
The main inclusion criteria include but are not limited to the following:
* 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
The main exclusion criteria include but are not limited to the following:
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 bleed…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Bomedemstat in Participants with Mild Hepatic Impairment (HI)
Timeframe: Up to 216 hours
2
Maximum Plasma Concentration (Cmax) of Bomedemstat in Participants with Mild HI
Timeframe: Up to 216 hours
3
AUC0-Inf of Bomedemstat in Participants with Moderate HI
Timeframe: Up to 216 hours
4
Cmax of Bomedemstat in Participants with Moderate HI