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Completed

NCT Number: NCT06860243

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

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.

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Key information

Conditions

Hepatic Impairment Healthy Participants

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opevesostat

Drug

Oral film-coated tablet

Other names: MK-5684

Prednisone

Drug

Oral tablet

fludrocortisone acetate

Drug

Oral tablet

Primary outcomes

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

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

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

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

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

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

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

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

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

  4. Maximum Observed Concentration (Cmax) of Opevesestat

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

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

  5. Time to Maximum Concentration (Tmax) of Opevesestat

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

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

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

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

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

  7. Apparent Clearance (CL/F) of Opevesestat

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

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

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

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

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

Secondary outcomes

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

    Time frame: 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.

  2. Number of Participants Who Discontinue Study Due to an AE

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-5684 in Male Participants With Moderate Hepatic Impairment

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2025
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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