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

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 1

Conditions: Hepatic Impairment; Healthy Participants

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06860243

MK-5684-009 (Other Identifier)

5684-009

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

The main inclusion criteria include but are not limited to the following:

• 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

The main exclusion criteria include but are not limited to the following:

• 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Moderate Hepatic Impairment

Experimental group

Description:

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.

Treatment:

Drug: Prednisone

Drug: Opevesostat

Drug: Fludrocortisone acetate

Healthy

Experimental group

Description:

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.

Treatment:

Drug: Prednisone

Drug: Opevesostat

Drug: Fludrocortisone acetate