Ulonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014)

An Open-Label, Single-Dose Clinical Study to Evaluate Pharmacokinetics of MK-8507 in Participants With Mild or Moderate Hepatic Impairment.

NCT05093972•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate pharmacokinetics (PK) and safety of a single oral dose of ulonivirine in participants with mild or moderate hepatic impairment (HI). It is hypothesized that the area under the plasma concentration-time curve from dosing to (extrapolated) infinity (AUC0-∞) in participants with mild or moderate HI is similar to that of healthy control participants.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Mild and Moderate HI (Panels A and B):
•Has a diagnosis of chronic (\>6 months), stable HI with features of cirrhosis due to any etiology (stability of hepatic disease should correspond to no acute episodes of illness within the previous 2 months due to deterioration in hepatic function)
•Healthy Controls (Panel C):
•Is in good health
•All Participants (Panels A to C):
•Has a body mass index (BMI) ≥18.5 and ≤40 kg/m\^2, inclusive
•If male, uses contraception in accordance with local regulations
•If female, is not pregnant or breastfeeding and one of the following applies: 1) is not a woman of childbearing potential (WOCBP), or 2) is a WOCBP and is abstinent/uses acceptable contraception, has a negative highly sensitive pregnancy test within 24 hours of receiving study intervention, and provides medical/menstrual/recent sexual history for review by the investigator

Exclusion Criteria

•Mild and Moderate HI (Panels A and B):
•Has a history of any illness that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study
•Is not in sufficient health
•Is institutionalized/mentally or legally incapacitated
•Is positive for human immunodeficiency virus (HIV)-1 or HIV-2
•Has received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to study start
•Is taking medication for a chronic condition and has not been on a stable regimen for ≥ 1 month
•Healthy Controls (Panel C):
•Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
•Is mentally or legally incapacitated
+7 more criteria

Key Dates

Start Date

April 7, 2026

Primary Completion Date

September 10, 2026

Completion Date

September 10, 2026

Last Updated

February 18, 2025

Enrollment

ESTIMATED participants

Conditions

Hepatic Insufficiency

Interventions

Ulonivirine

DRUG

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

NCT07343037

Hepatic InsufficiencyCirrhosis, Liver

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TERMINATEDPHASE1

A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies

NCT05209295

Hepatic InsufficiencyNeoplasms

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ulonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014)

Inclusion Criteria

Exclusion Criteria

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies

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A Study of Olomorasib (LY3537982) in Participants With Hepatic Impairment and Healthy Participants

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A Pharmacokinetic Study of Simufilam in Subjects With Impaired Hepatic Function