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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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