Hepatic InsufficiencyPhase 1NCT07049939
A Study of Bomedemstat (MK-3543) in Participants With Mild or Moderate Hepatic Impairment (MK-3543-023)
A Phase 1 study testing Bomedemstat in people with Hepatic Insufficiency, run by Merck Sharp & Dohme LLC at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Insufficiency
- What is being tested?
- Bomedemstat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Aug 2025to 17 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Miami ( Site 0003)
Miami, Florida, 33136
Orlando Clinical Research Center ( Site 0001)
Orlando, Florida, 32809
The Texas Liver Institute ( Site 0002)
San Antonio, Texas, 78215
About this study
Official title: An Open-Label, Single-Dose Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of MK-3543
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
- Being tested
- Bomedemstat
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BomedemstatDrug
Also called MK-3543
Capsule for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Mild Hepatic Impairment | Experimental | Participants with mild hepatic impairment will receive a single oral 25 mg dose of bomedemstat on Day 1. Receives: Drug: Bomedemstat |
| Moderate Hepatic Impairment | Experimental | Participants with mild hepatic impairment will receive a single oral 25 mg dose of bomedemstat on Day 1. Receives: Drug: Bomedemstat |
| Healthy Matched Control | Experimental | Healthy participants will receive a single oral 25 mg dose of bomedemstat on Day 1. Receives: Drug: Bomedemstat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Bomedemstat in Participants with Mild Hepatic Impairment (HI)
Blood samples collected to determine the AUC0-inf of bomedemstat.
Measured: Up to 216 hours
Maximum Plasma Concentration (Cmax) of Bomedemstat in Participants with Mild HI
Blood samples collected to determine the Cmax of bomedemstat.
Measured: Up to 216 hours
AUC0-Inf of Bomedemstat in Participants with Moderate HI
Blood samples collected to determine the AUC0-inf of bomedemstat.
Measured: Up to 216 hours
Cmax of Bomedemstat in Participants with Moderate HI
Blood samples collected to determine the Cmax of bomedemstat.
Measured: Up to 216 hours
Secondary outcomes (16)
Number of Participants Who Experience an Adverse Event (AE)
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.
Measured: Up to 14 days
Number of Participants Who Discontinue Study Due to an AE
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.
Measured: Up to 14 days
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Bomedemstat in Participants with Mild HI
Blood samples will be collected to determine the AUC0-last of bomedemstat.
Measured: Up to 216 hours
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Bomedemstat in Participants with Mild HI
Blood samples will be collected to determine the AUC0-24hr of bomedemstat.
Measured: At designated timepoints up to 24 hours postdose
Plasma Concentration at 24 Hours (C24) of Bomedemstat in Participants with Mild HI
Blood samples will be collected to determine the C24 of bomedemstat.
Measured: At designated timepoints up to 24 hours postdose
Time to Maximum Plasma Concentration (Tmax) of Bomedemstat in Participants with Mild HI
Blood samples will be collected to determine the Tmax of bomedemstat.
Measured: Up to 216 hours
Apparent Terminal Half-life (t1/2) of Bomedemstat in Participants with Mild HI
Blood samples will be collected to determine the t1/2 of bomedemstat.
Measured: Up to 216 hours
Apparent Clearance (CL/F) of Bomedemstat in Participants with Mild HI
Blood samples will be collected to determine the CL/F of bomedemstat.
Measured: Up to 216 hours
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Bomedemstat in Participants with Mild HI
Blood samples will be collected to determine the Vz/F of bomedemstat.
Measured: Up to 216 hours
AUC0-Last of Bomedemstat in Participants with Moderate HI
Blood samples will be collected to determine the AUC0-last of bomedemstat.
Measured: Up to 216 hours
AUC0-24hrs of Bomedemstat in Participants with Moderate HI
Blood samples will be collected to determine the AUC0-24hr of bomedemstat.
Measured: At designated timepoints up to 24 hours postdose
C24 of Bomedemstat in Participants with Moderate HI
Blood samples will be collected to determine the C24 of bomedemstat.
Measured: At designated timepoints up to 24 hours postdose
Tmax of Bomedemstat in Participants with Moderate HI
Blood samples will be collected to determine the Tmax of bomedemstat.
Measured: Up to 216 hours
t1/2 of Bomedemstat in Participants with Moderate HI
Blood samples will be collected to determine the t1/2 of bomedemstat.
Measured: Up to 216 hours
CL/F of Bomedemstat in Participants with Moderate HI
Blood samples will be collected to determine the CL/F of bomedemstat.
Measured: Up to 216 hours
Vz/F of Bomedemstat in Participants with Moderate HI
Blood samples will be collected to determine the Vz/F of bomedemstat.
Measured: Up to 216 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start20 Aug 2025
- Primary completion17 Feb 2026
- Study completion17 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic InsufficiencyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049939
- Sponsor's protocol ID
- 3543-023
- Other IDs
- MK-3543-023
- Status last verified
- Feb 2026
- First submitted
- 25 Jun 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of MK-3543
- ClinicalTrials.gov ID
- NCT07049939
- Acronym / sponsor ID
- 3543-023
- Conditions
- Hepatic Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 17 Feb 2026 (actual)
- Study completion
- 17 Feb 2026 (actual)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild Hepatic Impairment | Experimental | Drug: BomedemstatParticipants with mild hepatic impairment will receive a single oral 25 mg dose of bomedemstat on Day 1. |
| Moderate Hepatic Impairment | Experimental | Drug: BomedemstatParticipants with mild hepatic impairment will receive a single oral 25 mg dose of bomedemstat on Day 1. |
| Healthy Matched Control | Experimental | Drug: BomedemstatHealthy participants will receive a single oral 25 mg dose of bomedemstat on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Must match the mean age (± 15 years) of participants with mild HI and moderate HI
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BomedemstatAlso: MK-3543Capsule for oral administration | Drug | Healthy Matched Control, Mild Hepatic Impairment, Moderate Hepatic Impairment |
Primary outcome
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.
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.
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.
Cmax of Bomedemstat in Participants with Moderate HI
Time frame: Up to 216 hours
Blood samples collected to determine the Cmax of bomedemstat.
16 secondary outcomes
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to 14 days
Number of Participants Who Discontinue Study Due to an AE
Time frame: Up to 14 days
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
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
Plasma Concentration at 24 Hours (C24) of Bomedemstat in Participants with Mild HI
Time frame: At designated timepoints up to 24 hours postdose
Time to Maximum Plasma Concentration (Tmax) of Bomedemstat in Participants with Mild HI
Time frame: Up to 216 hours
Apparent Terminal Half-life (t1/2) of Bomedemstat in Participants with Mild HI
Time frame: Up to 216 hours
Apparent Clearance (CL/F) of Bomedemstat in Participants with Mild HI
Time frame: Up to 216 hours
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Bomedemstat in Participants with Mild HI
Time frame: Up to 216 hours
AUC0-Last of Bomedemstat in Participants with Moderate HI
Time frame: Up to 216 hours
AUC0-24hrs of Bomedemstat in Participants with Moderate HI
Time frame: At designated timepoints up to 24 hours postdose
C24 of Bomedemstat in Participants with Moderate HI
Time frame: At designated timepoints up to 24 hours postdose
Tmax of Bomedemstat in Participants with Moderate HI
Time frame: Up to 216 hours
t1/2 of Bomedemstat in Participants with Moderate HI
Time frame: Up to 216 hours
CL/F of Bomedemstat in Participants with Moderate HI
Time frame: Up to 216 hours
Vz/F of Bomedemstat in Participants with Moderate HI
Time frame: Up to 216 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bomedemstat in people with Hepatic Insufficiency, run by Merck Sharp & Dohme LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.