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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Pevifoscorvir Sodium (ALG-000184) Single oral doses of 100 mg pevifoscorvir sodium
Orlando Clinical Research Center
Orlando, Florida, United States
Genesis Clinical Trials
Tampa, Florida, United States
Area under the concentration time curve [AUC]
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Time frame: Up to 4 days
Maximum plasma concentration [Cmax]
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Time frame: Up to 4 Days
Minimum plasma concentration [Cmin]
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Time frame: Up to 4 Days
C0 [predose]
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Time frame: Up to 4 days
Half-life [t1/2]
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Time frame: Up to 4 Days
Time to maximum plasma concentration [Tmax]
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Time frame: Up to 4 Days
Apparent Clearance (CL/F)
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Time frame: Up to 4 Days
Apparent Volume of Distribution (V/F)
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Time frame: Up to 4 Days
Total Amount of Drug Excreted in Urine (Ae)
Urine PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Time frame: Up to 4 Days
Renal Clearance (CLr)
Urine PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Time frame: Up to 4 Days
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
Time frame: Up to 15 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.