A Study to Evaluate Opevesostat (MK-5684) in Male Participants With Moderate Hepatic Impairment (MK-5684-009)
NCT ID: NCT06860243
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
16 participants
INTERVENTIONAL
2025-05-13
2026-02-05
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Moderate Hepatic Impairment
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.
Opevesostat
Oral film-coated tablet
Prednisone
Oral tablet
Fludrocortisone acetate
Oral tablet
Healthy
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.
Opevesostat
Oral film-coated tablet
Prednisone
Oral tablet
Fludrocortisone acetate
Oral tablet
Interventions
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Opevesostat
Oral film-coated tablet
Prednisone
Oral tablet
Fludrocortisone acetate
Oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
MALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Clinical Pharmacology of Miami ( Site 0002)
Miami, Florida, United States
Texas Liver Institute ( Site 0001)
San Antonio, Texas, United States
Countries
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Other Identifiers
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MK-5684-009
Identifier Type: OTHER
Identifier Source: secondary_id
5684-009
Identifier Type: -
Identifier Source: org_study_id
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