The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability of S-217622 in participants with mild and moderate hepatic impairment compared with control participants with normal hepatic function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Tablet for oral administration
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States
Advanced Pharma CR, LLC
Miami, Florida, United States
Orlando Clinical Research Center, Inc.
Orlando, Florida, United States
Nucleus Network
Saint Paul, Minnesota, United States
Maximum Observed Plasma Concentration (Cmax) of S-217622
Time frame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
Time to Maximum Plasma Concentration (Tmax) of S-217622
Time frame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
Area Under the Plasma Concentration-Time Curve (AUC) of S-217622
Time frame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
Terminal Elimination Half-Life (t1/2,z) of S-217622
Time frame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
Terminal Elimination Rate Constant (λz) of S-217622
Time frame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
Mean Residence Time (MRT) of S-217622
Time frame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
Apparent Total Clearance (CL/F) of S-217622
Time frame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
Apparent Volume of Distribution (Vz/F) of S-217622
Time frame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
Renal Clearance (CLR) of S-217622
Time frame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
Fraction of Dose Excreted in Urine (Feu) of S-217622
Time frame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
Fraction Unbound in Plasma (FU) of S-217622
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Time frame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
Number of Participants with Treatment-Emergent Adverse Events
Time frame: Up to Day 21