drugset / Trial / NCT07342868

Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function

NCT07342868

Phase 1 Recruiting 16 enrolled Aligos Therapeutics
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This Phase 1 non-randomized, open-label, single-dose hepatic impairment study consists of 2 cohorts, conducted in 16 subjects, 8 subjects with moderate hepatic impairment (Cohort 1) and 8 subjects without hepatic impairment (Cohort 2), matched for age, body weight and, to the extent possible, for sex. The effect of hepatic impairment on the plasma pharmacokinetics of ALG-001075 will be assessed in subjects who have received single oral doses of pevifoscorvir sodium (ALG-000184).

Timeline

Start
2026-01-30
Primary completion
2026-04-20
Completion
2026-05-05

Drugs

EvaluationDrugModalityDoseRoute
Subject ALG-000184 Other / unclassified 100 mg Oral