Drug-Drug Interaction Study of Bomedemstat and Carbamazepine in Healthy Adult Participants (MK-3543-020)
- Registration Number
- NCT06596668
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
The main exclusion criteria include but are not limited to the following:
-
History or presence of any of the following:
- Seizures
- Negative reactions in the blood system to any drugs
- Depression, unusual changes in mood or behavior or suicidal thoughts or behavior
-
History of cancer
-
Regular user of cannabis products within 6 months before entering the study.
-
Unable to stop using or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days before entering the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bomedemstat + Carbamazepine bomedemstat A single dose of bomedemstat will be administered On Day 1 of Period 1. There will be a washout of 7 days between bomedemstat dosing in Period 1 and the first carbamazepine (CBZ) dose in Period 2. In Period 2, CBZ will be administered twice daily (BID) for 17 consecutive days, with a single dose of bomedemstat coadministered with the morning dose on Day 14. Bomedemstat + Carbamazepine carbamazepine A single dose of bomedemstat will be administered On Day 1 of Period 1. There will be a washout of 7 days between bomedemstat dosing in Period 1 and the first carbamazepine (CBZ) dose in Period 2. In Period 2, CBZ will be administered twice daily (BID) for 17 consecutive days, with a single dose of bomedemstat coadministered with the morning dose on Day 14.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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
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
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
Trial Locations
- Locations (1)
Celerion, Inc. ( Site 0001)
🇺🇸Tempe, Arizona, United States