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

NCT ID: NCT05093972

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-07
• Study Completion Date: 2026-09-10

Brief 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.

Conditions

Hepatic Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Panel A: Mild HI

Participants with mild HI receive a single oral dose of ulonivirine 400 mg on Day 1.

Group Type: EXPERIMENTAL

Ulonivirine

Intervention Type: DRUG

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

Panel B: Moderate HI

Participants with moderate HI receive a single oral dose of ulonivirine 400 mg on Day 1.

Group Type: EXPERIMENTAL

Ulonivirine

Intervention Type: DRUG

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

Panel C: Healthy Controls

Healthy matched control participants receive a single oral dose of ulonivirine 400 mg on Day 1.

Group Type: ACTIVE_COMPARATOR

Ulonivirine

Intervention Type: DRUG

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

Interventions

Ulonivirine

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

Intervention Type: DRUG

Other Intervention Names

MK-8507

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

MK-8507-014

Identifier Type: OTHER

Identifier Source: secondary_id

8507-014

Identifier Type: -

Identifier Source: org_study_id