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

NCT06860243 | Completed Phase 1 FDA Drug

• 2 other identifiers: 5684-009MK-5684-009
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatic Impairment; Healthy Participants

Outcome Measures

Primary Outcomes (8)

• Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) of Opevesestat

  Plasma samples will be collected to determine the AUC0-inf of opevesostat.

  At designated timepoints (up to approximately 96 hours post-dose)

• Area Under the Concentration Versus Time Curve from 0 to the Last Quantifiable Sample (AUC0-last) of Opevesestat

  Plasma samples will be collected to determine the AUC0-last of opevesostat.

  At designated timepoints (up to approximately 96 hours post-dose)

• Area Under the Concentration Versus Time Curve from 0 to 24 hours (AUC0-24) of Opevesestat

  Plasma samples will be collected to determine the AUC0-24 of opevesostat.

  At designated timepoints (up to approximately 24 hours post-dose)

• Maximum Observed Concentration (Cmax) of Opevesestat

  Plasma samples will be collected to determine the Cmax of opevesostat.

  At designated timepoints (up to approximately 96 hours post-dose)

• Time to Maximum Concentration (Tmax) of Opevesestat

  Plasma samples will be collected to determine the Tmax of opevesostat.

  At designated timepoints (up to approximately 96 hours post-dose)

• Apparent Terminal Half-life (t1/2) of Opevesestat

  Plasma samples will be collected to determine the t1/2 of opevesostat.

  At designated timepoints (up to approximately 96 hours post-dose)

• Apparent Clearance (CL/F) of Opevesestat

  Plasma samples will be collected to determine the CL/F of opevesostat.

  At designated timepoints (up to approximately 96 hours post-dose)

• Apparent Volume of Distribution During Terminal Phase (Vz/F) of Opevesestat

  Plasma samples will be collected to determine the Vz/F of opevesostat.

  At designated timepoints (up to approximately 96 hours post-dose)

Secondary Outcomes (2)

• Number of Participants Who Experience One or More Adverse Events (AEs)

  Up to approximately 2 weeks

• Number of Participants Who Discontinue Study Due to an AE

  Up to approximately 2 weeks

Study Arms (2)

Moderate Hepatic Impairment

EXPERIMENTAL

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.

Drug: Opevesostat; Drug: Prednisone; Drug: Fludrocortisone acetate

Healthy

EXPERIMENTAL

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.

Drug: Opevesostat; Drug: Prednisone; Drug: Fludrocortisone acetate

Interventions

Opevesostat DRUG

Oral film-coated tablet

Also known as: MK-5684

Healthy; Moderate Hepatic Impairment

Prednisone DRUG

Oral tablet

Healthy; Moderate Hepatic Impairment

Fludrocortisone acetate DRUG

Oral tablet

Healthy; Moderate Hepatic Impairment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants:
• Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing
• Has body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m2
• Participants with moderate hepatic impairment:
• Has a diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology

You may not qualify if:

• All participants:
• Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest, or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome (including Brugada syndrome)
• Has a history of cancer (malignancy)
• Has positive results for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
• Participants with moderate hepatic impairment
• Has unstable electrolyte abnormalities or electrolyte abnormalities that are considered difficult to manage for participants with hepatic impairment
• Has a history of liver or other solid organ transplantation

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (2)

Clinical Pharmacology of Miami ( Site 0002)

Miami, Florida, 33172, United States

Location

Texas Liver Institute ( Site 0001)

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Interventions

Prednisone; fludrocortisone acetate

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 5, 2025
• Study Start: May 13, 2025
• Primary Completion: February 9, 2026
• Study Completion: February 19, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (2)