NCT06633419

A Drug-Drug Interaction Study of Carbamazepine and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-012)

A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Carbamazepine on the Single-Dose Pharmacokinetics of MK-5684 in Healthy Adult Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Researchers have designed a study medicine called opevesostat as a new way to treat prostate cancer. The purpose of this study is to learn what happens to opevesostat in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to opevesostat in the body when it is given with and without another medicine called carbamazepine.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Opevesostat	Administered via oral tablet per dosing regimen.
DRUG	Prednisone	Administered at a dose of 5 mg or 10 mg dependent on HRT dosing regimen via oral tablets.
DRUG	Fludrocortisone acetate	Administered at a dose of 0.05 mg or 0.1 mg dependent on HRT dosing regimen via oral tablets.
DRUG	Carbamazepine	Administered at a dose of 100 mg, 200 mg, or 300 mg BID dependent on dosing regimen via oral capsule (extended-release).

Timeline

• Start date: 2024-12-18
• Primary completion: 2025-02-12
• Completion: 2025-05-13
• First posted: 2024-10-09
• Last updated: 2025-05-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study