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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3543-023 | Other Identifier | MSD |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild Hepatic Impairment | Experimental | Participants with mild hepatic impairment will receive a single oral 25 mg dose of bomedemstat on Day 1. |
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| Moderate Hepatic Impairment | Experimental | Participants with mild hepatic impairment will receive a single oral 25 mg dose of bomedemstat on Day 1. |
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| Healthy Matched Control | Experimental | Healthy participants will receive a single oral 25 mg dose of bomedemstat on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bomedemstat | Drug | Capsule for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 216 hours |
| Maximum Plasma Concentration (Cmax) of Bomedemstat in Participants with Mild HI | Blood samples collected to determine the Cmax of bomedemstat. | Up to 216 hours |
| AUC0-Inf of Bomedemstat in Participants with Moderate HI | Blood samples collected to determine the AUC0-inf of bomedemstat. | Up to 216 hours |
| Cmax of Bomedemstat in Participants with Moderate HI | Blood samples collected to determine the Cmax of bomedemstat. | Up to 216 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 14 days |
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Inclusion Criteria
The main inclusion criteria include but are not limited to the following:
Participants with Mild and Moderate HI
Healthy Control Participants:
Exclusion Criteria
The main exclusion criteria include but are not limited to the following:
All Participants
Participants with Mild and Moderate HI
Healthy Control Participants
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami ( Site 0003) | Miami | Florida | 33136 | United States | ||
| Orlando Clinical Research Center ( Site 0001) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000730033 | bomedemstat |
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| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to 216 hours |
| Orlando |
| Florida |
| 32809 |
| United States |
| The Texas Liver Institute ( Site 0002) | San Antonio | Texas | 78215 | United States |