drugset / Trial / NCT05093972

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

NCT05093972

Phase 1 Not yet recruiting 22 enrolled Merck Sharp & Dohme LLC
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2027-01-22
Primary completion
2027-06-29
Completion
2027-06-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Ulonivirine Small molecule 400 mg Oral

Indications