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Completed

NCT Number: NCT06596668

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

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).

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Inc. ( Site 0001)

Tempe, Arizona, 85283, United States

Who can participate

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:

  • 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.

Treatment and study plan

Bomedemstat

Drug

Oral tablet

Other names: MK-3543

carbamazepine

Drug

Oral extended-release capsule

Primary outcomes

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

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

    AUC0-inf for bomedemstat in plasma will be determined

Secondary outcomes

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

    Time frame: 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.

  2. Number of participants who discontinue study treatment due to an AE

    Time frame: 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.

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

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

    AUC0-last for bomedemstat in plasma will be determined

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

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

    AUC0-24 for bomedemstat in plasma will be determined

  5. Maximum observed concentration (Cmax) of bomedemstat

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

    Cmax for bomedemstat in plasma will be determined

  6. Maximum observed concentration 24 hours after dosing (C24) bomedemstat

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

    Cmax for bomedemstat in plasma will be determined

  7. Time to maximum concentration (Tmax) of bomedemstat

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

    Tmax for bomedemstat in plasma will be determined

  8. Apparent terminal half-life (t1/2) of bomedemstat

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

    t1/2 for bomedemstat in plasma will be determined

  9. Apparent clearance (CL/F) of bomedemstat

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

    CL/F for bomedemstat in plasma will be determined

  10. Apparent volume of distribution during terminal phase (Vz/F) of bomedemstat in plasma

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

    Vz/F for bomedemstat in plasma will be determined

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Mar 18, 2025

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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