The purpose of the study is to evaluate the pharmacokinetics and safety of parsaclisib in participants With normal renal function and participants with renal impairment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
48
parsaclisib will be administered orally after 8 hours of fasting.
Orange County Research Center
Tustin, California, United States
Clinical Pharmacology of Miami
Hialeah, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Prism Research
Saint Paul, Minnesota, United States
Pharmacokinetics Parameter Groups1-4 : Cmax of parsaclisib
Maximum Observed Plasma Concentration of parsaclisib
Time frame: 4 Days
Pharmacokinetics Parameter Groups 1-4 : AUC 0-∞ of parsaclisib
Area Under the Concentration-time Curve From 0 to Infinity of parsaclisib
Time frame: 4 Days
Pharmacokinetics Parameter Groups 1-4 : AUC(0-t) of parsaclisib
Area Under the concentration- time curve up to the last measurable concentration of parsaclisib
Time frame: 4 Days
Pharmacokinetics Parameter Group 5: Cmax of parsaclisib
Maximum Observed Plasma Concentration of parsaclisib
Time frame: 4 Days for period 1 and 2
Pharmacokinetics Parameter Group 5 : AUC 0-∞ of parsaclisib
Area Under the Concentration-time Curve From 0 to Infinity of parsaclisib
Time frame: 4 Days for period 1 and 2
Pharmacokinetics Parameter Group 5: AUC(0-t) of parsaclisib
Area Under the concentration- time curve up to the last measurable concentration of parsaclisib
Time frame: 4 Days for period 1 and 2
Number of Treatment Emergent Adverse Events (TEAE) Groups 1-4
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Time frame: up to 11 Days
Pharmacokinetics Parameter Groups 1-4 : tmax of parsaclisib
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Time to reach maximum plasma concentration of parsaclisib
Time frame: 4 Days
Pharmacokinetics Parameter Groups 1-4 : t1/2 of parsaclisib
Apparent terminal phase disposition half-life of parsaclisib
Time frame: 4 Days
Pharmacokinetics Parameter Groups 1-4 : CL/F of parsaclisib
Oral dose clearance of parsaclisib
Time frame: 4 Days
Pharmacokinetics Parameter Groups 1-4 : Vz/F of parsaclisib
Apparent oral dose volume of distribution of parsaclisib
Time frame: 4 Days
Pharmacokinetics Parameter Group 5 : tmax of parsaclisib
Time to reach maximum plasma concentration of parsaclisib
Time frame: 4 Days for period 1 and 2
Pharmacokinetics Parameter Group 5 : t1/2 of parsaclisib
Apparent terminal phase disposition half-life of parsaclisib
Time frame: 4 Days for period 1 and 2
Pharmacokinetics Parameter Group 5 : CL/F of parsaclisib
Oral dose clearance of parsaclisib
Time frame: 4 Days for period 1 and 2
Pharmacokinetics Parameter Group 5 : Vz/F of parsaclisib
Apparent oral dose volume of distribution of parsaclisib
Time frame: 4 Days for period 1 and 2
Pharmacokinetics Parameter Group 5 during Dialysis - : AUC1-5 of parsaclisib
Area Under the Concentration-time Curve From 1 to 5 hrs. of parsaclisib
Time frame: 4 Days for period 1 and 2
Number of Treatment Emergent Adverse Events (TEAE) Group 5
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Time frame: up to 18 Days