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: 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
Maximum Plasma Concentration [Cmax]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time frame: Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 1 ; Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 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, 24, 36, 48 hours post last dose 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), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 1 ; Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6
Apparent Clearance (CL/F)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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, 24, 36, 48 hours post last dose on day 6 only
Apparent Volume of Distribution (V/F)
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, 24, 36, 48 hours post last dose on day 6 only
Total Amount of Drug Excreted in Urine (Ae)
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine
Time frame: Collection intervals: 0-6, 6-12, 12-24, 24-36 and 36-48 hours after the last dose
Renal Clearance (CLr)
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine
Time frame: Collection intervals: 0-6, 6-12, 12-24, 24-36 and 36-48 hours after the last dose.
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