MedTrace Logo

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 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-02-04

No results posted yet for this study

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).

Conditions

  • Chronic Hepaititis B Infections

Interventions

DRUG

Pevifoscorvir Sodium (ALG-000184)

Pevifoscorvir Sodium (ALG-000184) Single oral doses of 100 mg pevifoscorvir sodium

Sponsors & Collaborators

  • Aligos Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-30
Primary Completion
2026-04-20
Completion
2026-05-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07342868 on ClinicalTrials.gov