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

NCT06596668 | Completed Phase 1 FDA Drug

• 2 other identifiers: 3543-020MK-3543-020
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

  AUC0-inf for bomedemstat in plasma will be determined

  Predose and at designated timepoints up to 168 hours postdose

Secondary Outcomes (10)

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

  Up to approximately 66 days

• Number of participants who discontinue study treatment due to an AE

  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

  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

  Predose and at designated timepoints up to 24 hours postdose

• Maximum observed concentration (Cmax) of bomedemstat

  Predose and at designated timepoints up to 168 hours postdose

Study Arms (1)

Bomedemstat + Carbamazepine

EXPERIMENTAL

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.

Drug: bomedemstat; Drug: carbamazepine

Interventions

bomedemstat DRUG

Oral tablet

Also known as: MK-3543

Bomedemstat + Carbamazepine

carbamazepine DRUG

Oral extended-release capsule

Bomedemstat + Carbamazepine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion, Inc. ( Site 0001)

Tempe, Arizona, 85283, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

bomedemstat; Carbamazepine

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: October 2, 2024
• Primary Completion: February 5, 2025
• Study Completion: March 11, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)