The purpose of the study is to evaluate the pharmacokinetics and safety of parsaclisib in participants With normal hepatic function and participants with hepatic impairment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
21
parsaclisib will be administered orally after 8 hours of fasting.
Inland Empire Liver Foundation
Rialto, California, United States
Orange County Research Center
Tustin, California, United States
Clinical Pharmacology of Miami
Hialeah, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Pharmacokinetics Parameter : Cmax of parsaclisib
Maximum Observed Plasma Concentration of parsaclisib
Time frame: 5 Days
Pharmacokinetics Parameter : AUC 0-∞ of parsaclisib
Area Under the Concentration-time Curve From 0 to Infinity of parsaclisib
Time frame: 5 Days
Pharmacokinetics Parameter : AUC(0-t) of parsaclisib
Area Under the concentration- time curve up to the last measurable concentration of parsaclisib
Time frame: 5 Days
Number of Treatment Emergent Adverse Events (TEAE)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Time frame: Up to10 Days
Pharmacokinetics Parameter : tmax of parsaclisib
Time to reach maximum plasma concentration of parsaclisib
Time frame: 5 Days
Pharmacokinetics Parameter : t1/2 of parsaclisib
Apparent terminal phase disposition half-life of parsaclisib
Time frame: 5 Days
Pharmacokinetics Parameter : CL/F of parsaclisib
Oral dose clearance of parsaclisib
Time frame: 5 Days
Pharmacokinetics Parameter : Vz/F of parsaclisib
Apparent oral dose volume of distribution of parsaclisib
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Texas Liver Institute Tli the Liver Institute of South Texas List Downtown Office
San Antonio, Texas, United States
Time frame: 5 Days