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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMerck Sharp & Dohme LLC

About this trial

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.

Eligibility criteria

Qualifiers

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)

Is in good health

Has a body mass index (BMI) ≥18.5 and ≤40 kg/m², inclusive

If male, uses contraception in accordance with local regulations

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ulonivirine

Treatment groups

22 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators