A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001)
NCT06136598 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2026-03-19
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
- DRUG
-
Opevesostat
Tablets to be taken orally.
- DRUG
-
Tablets to be taken orally
- DRUG
-
Fludrocortisone
Tablets to be taken orally.
- DRUG
-
Hydrocortisone
Tablet to be taken orally as a rescue medication.
Sponsors & Collaborators
-
Orion Corporation, Orion Pharma
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-30
- Primary Completion
- 2026-03-09
- Completion
- 2026-03-09
Countries
- China
Study Locations
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