Evaluate Taste and Relative Bioavailability of Two Microsphere Formulations of Crizotinib in Healthy Participants
Status:
Completed
Trial end date:
2019-10-17
Target enrollment:
Participant gender:
Summary
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.