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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: bomedemstat; Drug: carbamazepine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06596668

3543-020

MK-3543-020 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Bomedemstat + Carbamazepine

Experimental group

Description:

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.

Treatment:

Drug: carbamazepine

Drug: bomedemstat