This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with moderate hepatic impairment and subjects without hepatic 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 hepatic 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
16
Multiple doses of ALG-097558 200 mg (2 x 100 mg tablets)
University of Miami
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Area Under the Concentration Time Curve [AUC]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time frame: AUC(0-12): Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12h post last dose on days 1 and 6; AUC(0-last): Predose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12h post last dose on day 1 and 6, and additionally 14, 24, 36 and 48h on day 6 only
Time to Maximum Plasma Concentration [Tmax]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time frame: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 1; Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, and 48 hours post last dose on day 6
Maximum Plasma Concentration [Cmax]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time frame: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 1; Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, and 48 hours post last dose on day 6
Minimum Plasma Concentration [Cmin]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time frame: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 6 only
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), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, and 48 hours post last dose on day 6 only
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time frame: Up to 20 Days
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