Healthy Clinical Trial
Official title:
A Phase 1, Randomized, Crossover, Open-Label, 4 Period Study In Healthy Volunteers To Demonstrate The Lack Of Effect Of Rabeprazole And Food On The Pharmacokinetics Of PF-06463922 And To Assess The Relative Bioavailability Of Oral Solution To The Tablet Formulation Of PF-06463922
The current study will be conducted in healthy adult subjects to evaluate the effect of proton pump inhibitor and food on pharmacokinetics of PF-06463922, to evaluate the bioavailability of the oral solution relative to the tablet formulation of PF-06463922.
PF-06463922 is a selective, ATP competitive small molecule tyrosine kinase inhibitor (TKI)
of the Anaplastic Lymphoma Kinase (ALK) positive (ALK+) or ROS oncogene 1 (ROS1) positive
(ROS1+) receptor tyrosine kinases (RTK) that also potently inhibits ALK kinase domain
mutations responsible for resistance to crizotinib. PF-06463922 is being developed as a
novel anticancer agent for the treatment of patients with advanced ALK+ NSCLC or ROS1+
NSCLC.
The current study is a Phase 1, randomized, open label, 4 period, 4 treatment, 4 sequence,
crossover study conducted in healthy adult subjects. Each subject will receive four single
oral doses of 100 mg PF-06463922 as tablets alone, tablets with food, tablets with
rabeprazole, and oral solution after overnight fasting with at least a 10 day washout period
between each PF-06463922 dose.
Twenty four (24) subjects will be enrolled to obtain at least 20 evaluable subjects who
complete all treatments. Subjects who withdraw will not be replaced unless the total number
of completed subjects falls below 20.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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