NCT06596668

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	bomedemstat	Oral tablet
DRUG	carbamazepine	Oral extended-release capsule

Timeline

• Start date: 2024-10-02
• Primary completion: 2025-02-05
• Completion: 2025-03-11
• First posted: 2024-09-19
• Last updated: 2025-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study