NCT06136598

A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001)

A Phase 1 Clinical Study to Investigate the Safety and Pharmacokinetics of MK-5684 in China Participants With Metastatic Castration-Resistant Prostate Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to evaluate the safety and tolerability of opevesostat in the treatment of male Chinese participants with metastatic castration-resistant prostate cancer (mCRPC) and to characterize the pharmacokinetic profile of opevesostat. There are no formal hypotheses to be tested in this study.

Conditions

• Prostatic Neoplasms
• Metastatic Castration-Resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Opevesostat	Tablets to be taken orally.
DRUG	Dexamethasone	Tablets to be taken orally
DRUG	Fludrocortisone	Tablets to be taken orally.
DRUG	Hydrocortisone	Tablet to be taken orally as a rescue medication.

Timeline

• Start date: 2024-01-30
• Primary completion: 2026-03-09
• Completion: 2026-03-09
• First posted: 2023-11-18
• Last updated: 2026-03-19

Locations

3 sites across 1 country: China