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

Hepatic Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05093972
• Other study ID #: 8507-014
• Secondary ID: MK-8507-014
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 7, 2025
• Est. completion date: September 10, 2025

Study information

• Verified date: May 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: September 10, 2025
• Est. primary completion date: September 10, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Liver Failure

Intervention

Drug:
• Ulonivirine
Four ulonivirine 100 mg tablets (total dose 400 mg) taken by mouth.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration-Time Curve from Dosing to Infinity (AUC0-8) of Ulonivirine	The AUC0-8 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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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

External Links

•   Merck Clinical Trials Information