This is an open-label, randomized, cross-over, single dose study in healthy volunteers to evaluate the potential effect of esomeprazole, a proton pump inhibitor, on the pharmacokinetics of crizotinib. Each subject enrolled will receive two single oral doses of crioztinib with or without esomeprazole separated by a washout period of at least 14 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
Each subject in Treatment A will receive a 250 mg single oral dose of crizotinib administered in a fasted state as 1x 250 mg Formulated Capsule on Day 1 and each subject in Treatment B will receive a 250 mg single oral dose of crizotinib administered in a fasted state as 1x 250 mg Formulated Capsule on Day 5
Each subject in Treatment B will receive 40 mg daily dose of esomeprazole from Day 1 to Day 5
Pfizer Investigational Site
Brussels, Belgium
Plasma AUCinf [area under the plasma concentration-time profile from time 0 to infinite time] for crizotinib
Time frame: 2 months
Plasma Cmax [maximum observed concentration] for crizotinib
Time frame: 2 months
Plasma AUClast [area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration] for crizotinib
Time frame: 2 months
Plasma Tmax [time for maximum observed concentration] for crizotinib
Time frame: 2 months
Plasma t1/2 [terminal half-life] for crizotinib
Time frame: 2 months
Plasma CL/F [apparent oral clearance] for crizotinib
Time frame: 2 months
Plasma Vz/F [apparent volume of distribution] for crizotinib
Time frame: 2 months
Plasma AUClast for metabolite (PF-06260182) if appropriate
Time frame: 2 months
crizotinib/metabolite AUClast ratio if appropriate
Time frame: 2 months
Plasma AUCinf for metabolite (PF-06260182) if appropriate
Time frame: 2 months
crizotinib/metabolite AUCinf ratio if appropriate
Time frame: 2 months
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Plasma Cmax for metabolite (PF-06260182) if appropriate
Time frame: 2 months
crizotinib/metabolite Cmax ratio if appropriate
Time frame: 2 months
Plasma Tmax for metabolite (PF-06260182) if appropriate
Time frame: 2 months