A Study to Evaluate Opevesostat (MK-5684) in Male Participants With Moderate Hepatic Impairment (MK-5684-009)

Phase 1

Recruiting

• Conditions: Hepatic Impairment; Healthy Participants
• Interventions: Drug: Opevesostat; Drug: Prednisone; Drug: Fludrocortisone acetate

• Registration Number: NCT06860243
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Researchers have designed a study medicine called opevesostat as a new way to treat prostate cancer.

The purpose of this study is to learn what happens to opevesostat in a person's body over time (a pharmacokinetic \[PK\] study). Researchers will compare what happens to opevesostat in the body when it is given to healthy participants and participants with moderate hepatic (liver) impairment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-28
• Study First Submitted QC: 2025-02-28
• Study First Posted: 2025-03-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Study Start: 2025-05-16
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-08-05
• Study Completion: 2025-08-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate Hepatic Impairment	Opevesostat	On Day 1, participants with moderate hepatic impairment will receive a single oral dose of opevesostat under fasting conditions and a single dose of hormone replacement therapy (HRT) (prednisone and fludrocortisone acetate) under fed conditions approximately 4.5 hours after opevesostat dosing. Participants with moderate hepatic impairment will receive another dose of HRT on Day 2.
Moderate Hepatic Impairment	Prednisone	On Day 1, participants with moderate hepatic impairment will receive a single oral dose of opevesostat under fasting conditions and a single dose of hormone replacement therapy (HRT) (prednisone and fludrocortisone acetate) under fed conditions approximately 4.5 hours after opevesostat dosing. Participants with moderate hepatic impairment will receive another dose of HRT on Day 2.
Moderate Hepatic Impairment	Fludrocortisone acetate	On Day 1, participants with moderate hepatic impairment will receive a single oral dose of opevesostat under fasting conditions and a single dose of hormone replacement therapy (HRT) (prednisone and fludrocortisone acetate) under fed conditions approximately 4.5 hours after opevesostat dosing. Participants with moderate hepatic impairment will receive another dose of HRT on Day 2.
Healthy	Opevesostat	On Day 1, healthy participants will receive a single oral dose of opevesostat under fasting conditions and a single dose of HRT (prednisone and fludrocortisone acetate) under fed conditions approximately 4.5 hours after opevesostat dosing.
Healthy	Prednisone	On Day 1, healthy participants will receive a single oral dose of opevesostat under fasting conditions and a single dose of HRT (prednisone and fludrocortisone acetate) under fed conditions approximately 4.5 hours after opevesostat dosing.
Healthy	Fludrocortisone acetate	On Day 1, healthy participants will receive a single oral dose of opevesostat under fasting conditions and a single dose of HRT (prednisone and fludrocortisone acetate) under fed conditions approximately 4.5 hours after opevesostat dosing.

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) of Opevesestat	At designated timepoints (up to approximately 96 hours post-dose)	Plasma samples will be collected to determine the AUC0-inf of opevesostat.
Area Under the Concentration Versus Time Curve from 0 to the Last Quantifiable Sample (AUC0-last) of Opevesestat	At designated timepoints (up to approximately 96 hours post-dose)	Plasma samples will be collected to determine the AUC0-last of opevesostat.
Area Under the Concentration Versus Time Curve from 0 to 24 hours (AUC0-24) of Opevesestat	At designated timepoints (up to approximately 24 hours post-dose)	Plasma samples will be collected to determine the AUC0-24 of opevesostat.
Maximum Observed Concentration (Cmax) of Opevesestat	At designated timepoints (up to approximately 96 hours post-dose)	Plasma samples will be collected to determine the Cmax of opevesostat.
Time to Maximum Concentration (Tmax) of Opevesestat	At designated timepoints (up to approximately 96 hours post-dose)	Plasma samples will be collected to determine the Tmax of opevesostat.
Apparent Terminal Half-life (t1/2) of Opevesestat	At designated timepoints (up to approximately 96 hours post-dose)	Plasma samples will be collected to determine the t1/2 of opevesostat.
Apparent Clearance (CL/F) of Opevesestat	At designated timepoints (up to approximately 96 hours post-dose)	Plasma samples will be collected to determine the CL/F of opevesostat.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Opevesestat	At designated timepoints (up to approximately 96 hours post-dose)	Plasma samples will be collected to determine the Vz/F of opevesostat.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experience One or More Adverse Events (AEs)	Up to approximately 2 weeks	An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Number of Participants Who Discontinue Study Due to an AE	Up to approximately 2 weeks	An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Trial Locations

Locations (2)

Clinical Pharmacology of Miami ( Site 0002); 🇺🇸 Miami, Florida, United States

Texas Liver Institute ( Site 0001); 🇺🇸 San Antonio, Texas, United States