Healthy
Conditions
Brief summary
Researchers have designed a study medicine called bomedemstat (MK-3543) as a new way to treat certain rare blood diseases. The purpose of this study is to learn what happens to bomedemstat in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to bomedemstat in the body when it is given alone and after multiple doses of another medicine called carbamazepine (CBZ).
Interventions
DRUGbomedemstat
Oral tablet
DRUGcarbamazepine
Oral extended-release capsule
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months before entering the study. * Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\^2 * Medically healthy with no clinically significant medical history
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of bomedemstat | Predose and at designated timepoints up to 168 hours postdose | AUC0-inf for bomedemstat in plasma will be determined |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who discontinue study treatment due to an AE | Up to approximately 25 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of bomedemstat | Predose and at designated timepoints up to 168 hours postdose | AUC0-last for bomedemstat in plasma will be determined |
| Area under the concentration versus time curve from 0 to 24 hours after dosing (AUC0-24) of bomedemstat | Predose and at designated timepoints up to 24 hours postdose | AUC0-24 for bomedemstat in plasma will be determined |
| Maximum observed concentration (Cmax) of bomedemstat | Predose and at designated timepoints up to 168 hours postdose | Cmax for bomedemstat in plasma will be determined |
| Number of participants who experience one or more adverse events (AEs) | Up to approximately 66 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Time to maximum concentration (Tmax) of bomedemstat | Predose and at designated timepoints up to 168 hours postdose | Tmax for bomedemstat in plasma will be determined |
| Apparent terminal half-life (t1/2) of bomedemstat | Predose and at designated timepoints up to 168 hours postdose | t1/2 for bomedemstat in plasma will be determined |
| Apparent clearance (CL/F) of bomedemstat | Predose and at designated timepoints up to 168 hours postdose | CL/F for bomedemstat in plasma will be determined |
| Apparent volume of distribution during terminal phase (Vz/F) of bomedemstat in plasma | Predose and at designated timepoints up to 168 hours postdose | Vz/F for bomedemstat in plasma will be determined |
| Maximum observed concentration 24 hours after dosing (C24) bomedemstat | Predose and at designated timepoints up to 24 hours postdose | Cmax for bomedemstat in plasma will be determined |
Countries
United States
Outcome results
None listed