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NCT05093972

PHASE1

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

Sponsor: 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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04-07

Completion Date

2026-09-10

Last Updated

2025-02-18

Healthy Volunteers

Yes

Conditions

Hepatic Insufficiency

Interventions

DRUG

Ulonivirine

Four ulonivirine 100 mg tablets (total dose 400 mg) taken by mouth.

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 * Is positive for hepatitis B virus surface antigen (HBsAg), hepatitis C antibodies, HIV-1, or HIV-2 * Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to first dose of study drug All Participants (Panel A to C): * Has a history of cancer (malignancy) * Has a history of significant multiple and/or severe allergies * Has known hypersensitivity to the active substance or any of the excipients of the study drug * Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to Screening