A Study of Bomedemstat (MK-3453) in Participants With Mild or Moderate Hepatic Impairment (MK-3453-023)

Launched by MERCK SHARP & DOHME LLC · Jun 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a medicine called bomedemstat (MK-3453) behaves in the body, especially in people who have mild or moderate liver problems. The goal is to see if the liver condition affects how the medicine is processed compared to people with healthy livers. To do this, participants will be divided into three groups: those with mild liver impairment, those with moderate liver impairment, and healthy volunteers who are similar in age, body size, and sex to the liver groups.

People who may join the study include adults with stable, long-term liver problems classified as mild or moderate using a standard scoring system called Child-Pugh. Healthy volunteers without significant health issues will also be included for comparison. Everyone in the study will take a single dose of bomedemstat by mouth on the first day, and researchers will monitor how the medicine moves through their bodies. The study is not yet recruiting, and certain people, such as those with recent serious liver complications, cancer, or active infections, will not be eligible. This research helps doctors understand how to safely use bomedemstat in people with liver conditions.

Gender

ALL

Eligibility criteria

• • 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
• • 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
• • Has transjugular intrahepatic portosystemic shunt and/or has undergone portacaval shunting
• • Is positive for Hepatitis C virus (HCV)
• • Is positive for Hepatitis B surface antigen (HBsAg)
• • Healthy Control Participants
• • Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
• • Is a regular user of cannabis products within approximately 6 months of study