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

NCT05093972 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 8507-014MK-8507-014
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Percentage of Participants with an Adverse Event (AE)

  Up to 21 days

Study Arms (3)

Panel A: Mild HI

EXPERIMENTAL

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

Drug: Ulonivirine

Panel B: Moderate HI

EXPERIMENTAL

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

Drug: Ulonivirine

Panel C: Healthy Controls

ACTIVE COMPARATOR

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

Drug: Ulonivirine

Interventions

Ulonivirine DRUG

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

Also known as: MK-8507

Panel A: Mild HI; Panel B: Moderate HI; Panel C: Healthy Controls

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

ulonivirine

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 26, 2021
• Study Start: April 7, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share