Clinical trial NCT06596668: Drug-Drug Interaction Study of Bomedemstat and Carbamazepine in Healthy Adult Participants (MK-3543-020)
Official title: An Open-Label, Phase 1 Study to Characterize the Effects of a Strong Cytochrome P450 3A4 Inducer on the Pharmacokinetics of Bomedemstat in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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 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.

Primary outcomes:
measure: Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of bomedemstat
timeFrame: Predose and at designated timepoints up to 168 hours postdose
Secondary outcomes:
measure: Number of participants who experience one or more adverse events (AEs)
timeFrame: Up to approximately 66 days
measure: Number of participants who discontinue study treatment due to an AE
timeFrame: Up to approximately 25 days
measure: Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of bomedemstat
timeFrame: Predose and at designated timepoints up to 168 hours postdose
measure: Area under the concentration versus time curve from 0 to 24 hours after dosing (AUC0-24) of bomedemstat
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: Maximum observed concentration (Cmax) of bomedemstat
timeFrame: Predose and at designated timepoints up to 168 hours postdose
measure: Maximum observed concentration 24 hours after dosing (C24) bomedemstat
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: Time to maximum concentration (Tmax) of bomedemstat
timeFrame: Predose and at designated timepoints up to 168 hours postdose
measure: Apparent terminal half-life (t1/2) of bomedemstat
timeFrame: Predose and at designated timepoints up to 168 hours postdose
measure: Apparent clearance (CL/F) of bomedemstat
timeFrame: Predose and at designated timepoints up to 168 hours postdose
measure: Apparent volume of distribution during terminal phase (Vz/F) of bomedemstat in plasma
timeFrame: Predose and at designated timepoints up to 168 hours postdose
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion, Inc. ( Site 0001)
state: Arizona
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: