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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-02

Study Completion Date

2025-03-11

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bomedemstat + 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.

Group Type EXPERIMENTAL

bomedemstat

Intervention Type DRUG

Oral tablet

carbamazepine

Intervention Type DRUG

Oral extended-release capsule

Interventions

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bomedemstat

Oral tablet

Intervention Type DRUG

carbamazepine

Oral extended-release capsule

Intervention Type DRUG

Other Intervention Names

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MK-3543

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes