drugset
drugset / Trial / NCT06136598

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

NCT06136598 ↗

Phase 1 Completed 14 enrolled Merck Sharp & Dohme LLC Orion Corporation, Orion Pharma · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-01-30
Primary completion
2026-03-09
Completion
2026-03-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Opevesostat Small molecule — Oral
Background Dexamethasone Small molecule — Oral
Background Fludrocortisone Other / unclassified — Oral
Background Hydrocortisone Other / unclassified — Oral

Indications

castration-resistant prostate carcinoma