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).
Male and Female between 18 and 75 years old
BMI 17.5 to 40.0 kg/m² and a total body weight >50 kg (110 lb)
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
Female subjects must have a negative serum pregnancy test at screening
Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.
Subjects with a history of clinically significant drug allergy
Subjects with a recent (within 1 year of randomization) history or current evidence of drug abuse or recreational drug use
Parallel
Pevifoscorvir Sodium (ALG-000184)
DrugPevifoscorvir Sodium (ALG-000184) Single oral doses of 100 mg pevifoscorvir sodium
Area under the concentration time curve [AUC]
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
Time to maximum plasma concentration [Tmax]
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
Maximum plasma concentration [Cmax]
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
Minimum plasma concentration [Cmin]
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
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