OncRef

Clinical Trial: NCT06136598

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

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Merck Sharp & Dohme LLC
Information Provided By:Merck Sharp & Dohme LLC
Last Update Posted:2026-03-19

Study Overview

Brief 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.

Official Title

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

Conditions

Prostatic Neoplasms, Metastatic Castration-Resistant Prostate Cancer

Intervention / Treatment

  • Drug: Opevesostat
  • Drug: Dexamethasone
  • Drug: Fludrocortisone
  • Drug: Hydrocortisone

Other Study ID Numbers

  • 5684-001
  • MK-5684-001

Start Date (Actual)

2024-01-30

Primary Completion Date (Actual)

2026-03-09

Study Completion Date (Actual)

2026-03-09

Enrollment (Actual)

14

Study Type

Interventional

Phase

Phase 1