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

Not Applicable

Not yet recruiting

• Conditions: Hepatic Insufficiency
• Interventions: Drug: MK-3543

• Registration Number: NCT07049939
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to learn what happens to bomedemstat (MK-3453) 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-25
• Study First Submitted QC: 2025-06-25
• Last Update Submitted: 2025-06-25
• Study First Posted: 2025-07-03
• Last Update Posted: 2025-07-03
• Study Start: 2025-07-07
• Primary Completion: 2025-11-16
• Study Completion: 2025-12-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Mild Hepatic Impairment	MK-3543	Participants with mild hepatic impairment will receive a single oral 25 mg dose of bomedemstat on Day 1.
Moderate Hepatic Impairment	MK-3543	Participants with mild hepatic impairment will receive a single oral 25 mg dose of bomedemstat on Day 1.
Healthy Matched Control	MK-3543	Healthy participants will receive a single oral 25 mg dose of bomedemstat on Day 1.

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Bomedemstat in Participants with Mild Hepatic Impairment (HI)	Up to 216 hours	Blood samples collected to determine the AUC0-inf of bomedemstat.
Maximum Plasma Concentration (Cmax) of Bomedemstat in Participants with Mild HI	Up to 216 hours	Blood samples collected to determine the Cmax of bomedemstat.
AUC0-Inf of Bomedemstat in Participants with Moderate HI	Up to 216 hours	Blood samples collected to determine the AUC0-inf of bomedemstat.
Cmax of Bomedemstat in Participants with Moderate HI	Up to 216 hours	Blood samples collected to determine the Cmax of bomedemstat.

Secondary Outcome Measures

Name	Time	Method
Time to Maximum Plasma Concentration (Tmax) of Bomedemstat in Participants with Mild HI	Up to 216 hours	Blood samples will be collected to determine the Tmax of bomedemstat.
Number of Participants Who Experience an Adverse Event (AE)	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.
Number of Participants Who Discontinue Study Due to an AE	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.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Bomedemstat in Participants with Mild HI	Up to 216 hours	Blood samples will be collected to determine the AUC0-last of bomedemstat.
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Bomedemstat in Participants with Mild HI	At designated timepoints up to 24 hours postdose	Blood samples will be collected to determine the AUC0-24hr of bomedemstat.
Plasma Concentration at 24 Hours (C24) of Bomedemstat in Participants with Mild HI	At designated timepoints up to 24 hours postdose	Blood samples will be collected to determine the C24 of bomedemstat.
Apparent Terminal Half-life (t1/2) of Bomedemstat in Participants with Mild HI	Up to 216 hours	Blood samples will be collected to determine the t1/2 of bomedemstat.
Apparent Clearance (CL/F) of Bomedemstat in Participants with Mild HI	Up to 216 hours	Blood samples will be collected to determine the CL/F of bomedemstat.
AUC0-Last of Bomedemstat in Participants with Moderate HI	Up to 216 hours	Blood samples will be collected to determine the AUC0-last of bomedemstat.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Bomedemstat in Participants with Mild HI	Up to 216 hours	Blood samples will be collected to determine the Vz/F of bomedemstat.
Tmax of Bomedemstat in Participants with Moderate HI	Up to 216 hours	Blood samples will be collected to determine the Tmax of bomedemstat.
AUC0-24hrs of Bomedemstat in Participants with Moderate HI	At designated timepoints up to 24 hours postdose	Blood samples will be collected to determine the AUC0-24hr of bomedemstat.
C24 of Bomedemstat in Participants with Moderate HI	At designated timepoints up to 24 hours postdose	Blood samples will be collected to determine the C24 of bomedemstat.
t1/2 of Bomedemstat in Participants with Moderate HI	Up to 216 hours	Blood samples will be collected to determine the t1/2 of bomedemstat.
CL/F of Bomedemstat in Participants with Moderate HI	Up to 216 hours	Blood samples will be collected to determine the CL/F of bomedemstat.
Vz/F of Bomedemstat in Participants with Moderate HI	Up to 216 hours	Blood samples will be collected to determine the Vz/F of bomedemstat.