The purpose of this study is to measure the pharmacokinetics, safety, and tolerability of S-892216 (S-892216-PO) in participants with mild, moderate, or severe renal impairment not on dialysis, or renal impairment requiring hemodialysis (HD), and in participants with normal renal function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
S-892216-PO tablet will be administered orally.
Orlando Clicinal Research Center
Orlando, Florida, United States
Global Clinical Professionals (GCP) LLC
St. Petersburg, Florida, United States
Genesis Clinical Research
Tampa, Florida, United States
Alliance for Multispecialty Research (AMR)-Knoxville
Knoxville, Tennessee, United States
Maximum Plasma Concentration (Cmax) of S-892216
Time frame: Day 1 (predose up to 504 hours postdose) and Day 29 (predose up to 72 hours postdose) for Group B participants only
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration After Dosing (AUC0-last) of S-892216
Time frame: Day 1 (predose up to 504 hours postdose) and Day 29 (predose up to 72 hours postdose) for Group B participants only
Group B Only: Cumulative Amount of the Drug Recovered in Dialysate (AHD) of S-892216
Time frame: Day 1 (up to 6 hours postdose)
Group B Only: Area Under the Dialysate Concentration in the Arterial Sides of Port-time Curve During Hemodialysis (AUChd) of S-892216
Time frame: Day 1 (up to 6 hours postdose)
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 through Day 39
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