A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005)
NCT06104449 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2026-04-27
Summary
The purpose of this study is to assess the efficacy and safety of opevesostat in the treatment of Japanese men with metastatic castration-resistant prostate cancer (mCRPC) previously treated with Next Generation Hormonal Agent (NHA) and taxane-based chemotherapy.
Conditions
- Prostatic Neoplasms
- Metastatic Castration-Resistant Prostate Cancer
Interventions
- DRUG
-
Opevesostat
Tablets to be taken orally.
- DRUG
-
Tablets to be taken orally.
- DRUG
-
Fludrocortisone acetate
Tablet to be taken orally.
- DRUG
-
Hydrocortisone
Tablets to be taken orally as a recue 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
- 2023-11-14
- Primary Completion
- 2026-02-20
- Completion
- 2026-04-17
Countries
- Japan
Study Locations
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