This is a Phase 1 non-randomized, open-label, single-dose study of pevifoscorvir sodium (also known as ALG-000184) in participants with severe renal impairment (Part 1), in participants with mild or moderate renal impairment (Optional Part 2) and in participants without renal impairment (Parts 1 and 2), matched for age, body weight and, to the extent possible, for sex.
Male and Female between 18 and 75 years old
Body Mass Index (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
Good general health as defined by no clinically relevant abnormalities identified by Medical History and a vital signs, clinical laboratory and 12-lead electrocardiogram (ECG) assessment
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 and 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 recent history or clinical evidence at screening of significant (subjects with normal renal function) or unstable (subjects with renal impairment) 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]
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Maximum plasma concentration [Cmax]
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Minimum plasma concentration [Cmin]
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
C0 [predose]
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent events in subjects with renal impairment and subjects with normal renal function as assessed by DAIDS v2.1
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