Bomedemstat
DrugCapsule for oral administration
Other names: MK-3543
NCT Number: NCT07049939
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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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
University of Miami ( Site 0003), Miami, Florida, United States
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:
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
Capsule for oral administration
Other names: MK-3543
Time frame: Up to 216 hours
Blood samples collected to determine the AUC0-inf of bomedemstat.
Time frame: Up to 216 hours
Blood samples collected to determine the Cmax of bomedemstat.
Time frame: Up to 216 hours
Blood samples collected to determine the AUC0-inf of bomedemstat.
Time frame: Up to 216 hours
Blood samples collected to determine the Cmax of bomedemstat.
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.
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.
Time frame: Up to 216 hours
Blood samples will be collected to determine the AUC0-last of bomedemstat.
Time frame: At designated timepoints up to 24 hours postdose
Blood samples will be collected to determine the AUC0-24hr of bomedemstat.
Time frame: At designated timepoints up to 24 hours postdose
Blood samples will be collected to determine the C24 of bomedemstat.
Time frame: Up to 216 hours
Blood samples will be collected to determine the Tmax of bomedemstat.
Time frame: Up to 216 hours
Blood samples will be collected to determine the t1/2 of bomedemstat.
Time frame: Up to 216 hours
Blood samples will be collected to determine the CL/F of bomedemstat.
Time frame: Up to 216 hours
Blood samples will be collected to determine the Vz/F of bomedemstat.
Time frame: Up to 216 hours
Blood samples will be collected to determine the AUC0-last of bomedemstat.
Time frame: At designated timepoints up to 24 hours postdose
Blood samples will be collected to determine the AUC0-24hr of bomedemstat.
Time frame: At designated timepoints up to 24 hours postdose
Blood samples will be collected to determine the C24 of bomedemstat.
Time frame: Up to 216 hours
Blood samples will be collected to determine the Tmax of bomedemstat.
Time frame: Up to 216 hours
Blood samples will be collected to determine the t1/2 of bomedemstat.
Time frame: Up to 216 hours
Blood samples will be collected to determine the CL/F of bomedemstat.
Time frame: Up to 216 hours
Blood samples will be collected to determine the Vz/F of bomedemstat.
Merck Sharp & Dohme LLC
Industry
An Open-Label, Single-Dose Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of MK-3543
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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