Ulonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ulonivirine.
- Who it may be relevant to
- Registry conditions: Hepatic Insufficiency. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label, Single-Dose Clinical Study to Evaluate Pharmacokinetics of MK-8507 in Participants With Mild or Moderate Hepatic Impairment.
Overview
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.
Interventions
- Drug Ulonivirine
Four ulonivirine 100 mg tablets (total dose 400 mg) taken by mouth.
Primary outcome measures
- Area Under the Plasma Concentration-Time Curve from Dosing to Infinity (AUC0-∞) of Ulonivirine [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose]
Secondary outcome measures (1)
- Percentage of Participants with an Adverse Event (AE) [Time frame: Up to 21 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05093972 · 8507-014 · MK-8507-014