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NCT Number: NCT05093972

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ulonivirine

Drug

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

Other names: MK-8507

Primary outcomes

  1. 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

    The AUC0-∞ of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.

  2. 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

    The AUC0-last of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.

  3. 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

    The Cmax of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.

  4. 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

    The Tmax of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.

  5. 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

    The t½ of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.

  6. 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

    The CL/F of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.

  7. 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

    The Vz/F of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.

Secondary outcomes

  1. Percentage of Participants with an Adverse Event (AE)

    Time frame: Up to 21 days

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Oct 26, 2021
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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