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OpenTrials
Completed

NCT Number: NCT07049939

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Miami ( Site 0003), Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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

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

Treatment and study plan

Bomedemstat

Drug

Capsule for oral administration

Other names: MK-3543

Primary outcomes

  1. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Bomedemstat in Participants with Mild Hepatic Impairment (HI)

    Time frame: Up to 216 hours

    Blood samples collected to determine the AUC0-inf of bomedemstat.

  2. Maximum Plasma Concentration (Cmax) of Bomedemstat in Participants with Mild HI

    Time frame: Up to 216 hours

    Blood samples collected to determine the Cmax of bomedemstat.

  3. AUC0-Inf of Bomedemstat in Participants with Moderate HI

    Time frame: Up to 216 hours

    Blood samples collected to determine the AUC0-inf of bomedemstat.

  4. Cmax of Bomedemstat in Participants with Moderate HI

    Time frame: Up to 216 hours

    Blood samples collected to determine the Cmax of bomedemstat.

Secondary outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to 14 days

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing AEs will be reported.

  2. Number of Participants Who Discontinue Study Due to an AE

    Time frame: Up to 14 days

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study treatment due to an AE will be reported.

  3. Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Bomedemstat in Participants with Mild HI

    Time frame: Up to 216 hours

    Blood samples will be collected to determine the AUC0-last of bomedemstat.

  4. Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Bomedemstat in Participants with Mild HI

    Time frame: At designated timepoints up to 24 hours postdose

    Blood samples will be collected to determine the AUC0-24hr of bomedemstat.

  5. Plasma Concentration at 24 Hours (C24) of Bomedemstat in Participants with Mild HI

    Time frame: At designated timepoints up to 24 hours postdose

    Blood samples will be collected to determine the C24 of bomedemstat.

  6. Time to Maximum Plasma Concentration (Tmax) of Bomedemstat in Participants with Mild HI

    Time frame: Up to 216 hours

    Blood samples will be collected to determine the Tmax of bomedemstat.

  7. Apparent Terminal Half-life (t1/2) of Bomedemstat in Participants with Mild HI

    Time frame: Up to 216 hours

    Blood samples will be collected to determine the t1/2 of bomedemstat.

  8. Apparent Clearance (CL/F) of Bomedemstat in Participants with Mild HI

    Time frame: Up to 216 hours

    Blood samples will be collected to determine the CL/F of bomedemstat.

  9. Apparent Volume of Distribution During Terminal Phase (Vz/F) of Bomedemstat in Participants with Mild HI

    Time frame: Up to 216 hours

    Blood samples will be collected to determine the Vz/F of bomedemstat.

  10. AUC0-Last of Bomedemstat in Participants with Moderate HI

    Time frame: Up to 216 hours

    Blood samples will be collected to determine the AUC0-last of bomedemstat.

  11. AUC0-24hrs of Bomedemstat in Participants with Moderate HI

    Time frame: At designated timepoints up to 24 hours postdose

    Blood samples will be collected to determine the AUC0-24hr of bomedemstat.

  12. C24 of Bomedemstat in Participants with Moderate HI

    Time frame: At designated timepoints up to 24 hours postdose

    Blood samples will be collected to determine the C24 of bomedemstat.

  13. Tmax of Bomedemstat in Participants with Moderate HI

    Time frame: Up to 216 hours

    Blood samples will be collected to determine the Tmax of bomedemstat.

  14. t1/2 of Bomedemstat in Participants with Moderate HI

    Time frame: Up to 216 hours

    Blood samples will be collected to determine the t1/2 of bomedemstat.

  15. CL/F of Bomedemstat in Participants with Moderate HI

    Time frame: Up to 216 hours

    Blood samples will be collected to determine the CL/F of bomedemstat.

  16. Vz/F of Bomedemstat in Participants with Moderate HI

    Time frame: Up to 216 hours

    Blood samples will be collected to determine the Vz/F of bomedemstat.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2025
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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