Drug-Drug Interaction Study of Bomedemstat and Carbamazepine in Healthy Adult Participants (MK-3543-020)

Merck Sharp & Dohme LLC16 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

bomedemstatDRUG

Oral tablet

carbamazepineDRUG

Oral extended-release capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Celerion, Inc. ( Site 0001)

Tempe, Arizona, United States

Outcomes

Primary Outcomes

Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of bomedemstat

AUC0-inf for bomedemstat in plasma will be determined

Time frame: Predose and at designated timepoints up to 168 hours postdose

Secondary Outcomes

Number of participants who experience one or more adverse events (AEs)

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 frame: Up to approximately 66 days

Number of participants who discontinue study treatment due to an AE

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 frame: Up to approximately 25 days

Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of bomedemstat

AUC0-last for bomedemstat in plasma will be determined

Time frame: Predose and at designated timepoints up to 168 hours postdose

Area under the concentration versus time curve from 0 to 24 hours after dosing (AUC0-24) of bomedemstat

AUC0-24 for bomedemstat in plasma will be determined

Time frame: Predose and at designated timepoints up to 24 hours postdose

Maximum observed concentration (Cmax) of bomedemstat

Cmax for bomedemstat in plasma will be determined

Time frame: Predose and at designated timepoints up to 168 hours postdose

Data from ClinicalTrials.gov

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