Clinical trial NCT06860243: A Study to Evaluate Opevesostat (MK-5684) in Male Participants With Moderate Hepatic Impairment (MK-5684-009)
Official title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-5684 in Male Participants With Moderate Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hepatic Impairment
Healthy Participants
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-03-05
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) of Opevesestat
timeFrame: At designated timepoints (up to approximately 96 hours post-dose)
measure: Area Under the Concentration Versus Time Curve from 0 to the Last Quantifiable Sample (AUC0-last) of Opevesestat
timeFrame: At designated timepoints (up to approximately 96 hours post-dose)
measure: Area Under the Concentration Versus Time Curve from 0 to 24 hours (AUC0-24) of Opevesestat
timeFrame: At designated timepoints (up to approximately 24 hours post-dose)
measure: Maximum Observed Concentration (Cmax) of Opevesestat
timeFrame: At designated timepoints (up to approximately 96 hours post-dose)
measure: Time to Maximum Concentration (Tmax) of Opevesestat
timeFrame: At designated timepoints (up to approximately 96 hours post-dose)
measure: Apparent Terminal Half-life (t1/2) of Opevesestat
timeFrame: At designated timepoints (up to approximately 96 hours post-dose)
measure: Apparent Clearance (CL/F) of Opevesestat
timeFrame: At designated timepoints (up to approximately 96 hours post-dose)
measure: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Opevesestat
timeFrame: At designated timepoints (up to approximately 96 hours post-dose)
Secondary outcomes:
measure: Number of Participants Who Experience One or More Adverse Events (AEs)
timeFrame: Up to approximately 2 weeks
measure: Number of Participants Who Discontinue Study Due to an AE
timeFrame: Up to approximately 2 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami ( Site 0002)
state: Florida
city: San Antonio
country: United States
facility: Texas Liver Institute ( Site 0001)
state: Texas
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: