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

Merck Sharp & Dohme LLC16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Hepatic Impairment Healthy Participants

Interventions

OpevesostatDRUG

Oral film-coated tablet

PrednisoneDRUG

Oral tablet

Fludrocortisone acetateDRUG

Oral tablet

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Clinical Pharmacology of Miami ( Site 0002)

Miami, Florida, United States

Texas Liver Institute ( Site 0001)

San Antonio, Texas, United States