This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with severe renal impairment and subjects without renal impairment, matched for age, body weight and, to the extent possible, for gender. The primary purpose of this study is to characterize the effect of renal impairment on the plasma pharmacokinetics of ALG-097558 following administration of multiple, twice daily (Q12H) oral (PO) doses.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Multiple doses of ALG-097558 300 mg (3 x 100 mg tablets)
University of Miami
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Genesis Clinical Trials
Tampa, Florida, United States
Area under the concentration time curve [AUC]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time frame: Pre-dose (-0.75 hours) up to Day 8
Maximum plasma concentration [Cmax]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time frame: Pre-dose (-0.75 hours) up to Day 8
Minimum plasma concentration [Cmin]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time frame: Pre-dose (-0.75 hours) up to Day 8
C0 [predose]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time frame: Pre-dose (-0.75 hours) up to Day 8
Half-life [t1/2]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time frame: Pre-dose (-0.75 hours) up to Day 8
Time to maximum plasma concentration [Tmax]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time frame: Pre-dose (-0.75 hours) up to Day 8
Apparent Clearance (CL/F)
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time frame: Pre-dose (-0.75 hours) up to Day 8
Apparent Volume of Distribution (V/F)
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time frame: Pre-dose (-0.75 hours) up to Day 8
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Total Amount of Drug Excreted in Urine (Ae)
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine
Time frame: Pre-dose (-0.75 hours) up to Day 8
Renal Clearance (CLr)
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine
Time frame: Pre-dose (-0.75 hours) up to Day 8
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 (July 2017)
Time frame: Up to 20 Days