Healthy Volunteers Clinical Trial
Official title:
A PHASE 1, OPEN LABEL, CROSSOVER STUDY TO EVALUATE PALATABILITY AND RELATIVE BIOAVAILABILITY OF TWO PEDIATRIC MICROSPHERE FORMULATIONS OF CRIZOTINIB IN HEALTHY PARTICIPANTS
The primary purpose of the study is to estimate the relative bioavailability and palatability
of 2 new crizotinib formulations to the commercially available crizotinib formulated capsule
at a 250 mg dose administered under fasted conditions in adult healthy participants.
Additionally, this study aims to assess the safety and tolerability of crizotinib 250 mg
single dose in 4 formulations when given fasted, with high fat meal, or with a proton pump
inhibitor in healthy participants. Finally, this study will explore the effect of food or
proton pump inhibitor on the pharmacokinetics of the 2 new crizotinib formulations.
We hypothesize 1 of the 2 new crizotinib formulations will have improved relative
bioavailability and palatability than the formulated capsule under fasted or fed conditions
with or without a proton pump inhibitor.
n/a
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