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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatic Insufficiency
• Intervention / Treatment: Drug: Ulonivirine

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Panel A: Mild HI; Participants with mild HI receive a single oral dose of ulonivirine 400 mg on Day 1.	Drug: Ulonivirine; Four ulonivirine 100 mg tablets (total dose 400 mg) taken by mouth.; Other Names: MK-8507
Experimental: Panel B: Moderate HI; Participants with moderate HI receive a single oral dose of ulonivirine 400 mg on Day 1.	Drug: Ulonivirine; Four ulonivirine 100 mg tablets (total dose 400 mg) taken by mouth.; Other Names: MK-8507
Active Comparator: Panel C: Healthy Controls; Healthy matched control participants receive a single oral dose of ulonivirine 400 mg on Day 1.	Drug: Ulonivirine; Four ulonivirine 100 mg tablets (total dose 400 mg) taken by mouth.; Other Names: MK-8507

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Plasma Concentration-Time Curve from Dosing to Infinity (AUC0-∞) of Ulonivirine	The AUC0-∞ of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.	Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
Area Under the Plasma Concentration-Time Curve from Dosing to Last Measurable Concentration (AUC0-last) of Ulonivirine	The AUC0-last of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.	Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
Maximum Plasma Concentration (Cmax) of Ulonivirine	The Cmax of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.	Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
Time to Maximum Plasma Concentration (Tmax) of Ulonivirine	The Tmax of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.	Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
Apparent Plasma Terminal Half-life (t½) of Ulonivirine	The t½ of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.	Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
Apparent Total Clearance from Plasma After Oral Administration (CL/F) of Ulonivirine	The CL/F of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.	Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
Apparent Volume of Distribution during Terminal Phase (Vz/F) of Ulonivirine	The Vz/F of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.	Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with an Adverse Event (AE)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	Up to 21 days

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Estimated): April 7, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 10, 2026

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency
• Other Study ID Numbers: 8507-014; MK-8507-014 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No