A Phase 1 Non-Randomized, Open-Label, 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
Aligos Therapeutics
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).
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male and Female between 18 and 75 years old 2. BMI 17.5 to 40.0 kg/m\^2 and a total body weight \>50 kg (110 lb) 3. Female subjects must either be not of childbearing potential or if they are a woman of childbearing potential, they are only eligible if they and any non- sterile, male sexual partners agree to use highly effective contraceptive therapy 4. Female subjects must have a negative serum pregnancy test at screening Inclusion Criteria for Subjects with Normal Hepatic Function: 1. Good general health as defined by no clinically relevant abnormalities identified…
Interventions
- DrugPevifoscorvir Sodium (ALG-000184)
Pevifoscorvir Sodium (ALG-000184) Single oral doses of 100 mg pevifoscorvir sodium
Location
- Orlando Clinical Research CenterOrlando, Florida