The present study is being conducted to evaluate whether or not severe renal impairment has an effect on crizotinib Pharmacokinetics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
Single-dose oral 250 mg crizotinib in subjects with normal renal function (CLcr =\>90 mL/min)
Single-dose oral 250 mg crizotinib in subjects with severe renal impairment (CLcr \<30 mL/min)
Pfizer Investigational Site
Anaheim, California, United States
Pfizer Investigational Site
DeLand, Florida, United States
Pfizer Investigational Site
Saint Paul, Minnesota, United States
Plasma AUCinf (Area under the plasma concentration versus time curve from zero to infinity) for crizotinib
Time frame: 18 months
Plasma Cmax (Maximum plasma concentration) for crizotinib
Time frame: 18 months
Plasma AUClast (Area under the plasma concentration versus time curve from zero to the last quantifiable concentration) for crizotinib
Time frame: 18 months
Tmax (Time to Cmax) for crizotinib
Time frame: 18 months
t1/2 (terminal half-life) for crizotinib
Time frame: 18 months
CL/F (Apparent oral clearance) for crizotinib
Time frame: 18 months
Vz/F (Apparent volume of distribution after oral dose) for crizotinib
Time frame: 18 months
fu (fraction of unbound drug in plasma) for crizotinib
Time frame: 18 months
AUCinf,u (unbound AUCinf) for crizotinib
Time frame: 18 months
AUClast,u (unbound AUClast) for crizotinib
Time frame: 18 months
Cmax,u (unbound Cmax) for crizotinib
Time frame: 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CL/Fu (unbound apparent oral clearance) for crizotinib
Time frame: 18 months
CLR (Renal clearance) for crizotinib
Time frame: 18 months
Ae (Cumulative amount of drug recovered unchanged in the urine) for crizotinib
Time frame: 18 months
Ae% (Cumulative amount of drug recovered unchanged in the urine expressed as fraction of administered dose) for crizotinib
Time frame: 18 months
AUCinf (Area under the plasma concentration versus time curve from zero to infinity) for PF-06260182
Time frame: 18 months
AUClast (Area under the plasma concentration versus time curve from zero to the last quantifiable concentration) for PF-06260182
Time frame: 18 months
Cmax (Maximum plasma concentration) for PF-06260182
Time frame: 18 months
Tmax (Time to Cmax) for PF-06260182
Time frame: 18 months
t1/2 (terminal half-life) for PF-06260182
Time frame: 18 months
fu (fraction of unbound drug in plasma) for PF-06260182
Time frame: 18 months
AUCinf,u (unbound AUCinf) for PF-06260182
Time frame: 18 months
AUClast,u (unbound AUClast) for PF-06260182
Time frame: 18 months
Cmax,u (unbound Cmax) for PF-06260182
Time frame: 18 months