NCT06860243

A Study to Evaluate Opevesostat (MK-5684) in Male Participants With Moderate Hepatic Impairment (MK-5684-009)

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-5684 in Male Participants With Moderate Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Male
• Age: 18 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 \[PK\] study). Researchers will compare what happens to opevesostat in the body when it is given to healthy participants and participants with moderate hepatic (liver) impairment.

Conditions

• Hepatic Impairment
• Healthy Participants

Interventions

Type	Name	Description
DRUG	Opevesostat	Oral film-coated tablet
DRUG	Prednisone	Oral tablet
DRUG	Fludrocortisone acetate	Oral tablet

Timeline

• Start date: 2025-05-13
• Primary completion: 2026-02-09
• Completion: 2026-02-19
• First posted: 2025-03-05
• Last updated: 2026-02-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study