PPI And Food Effect Study For PF-06463922 In Healthy Volunteers
|ClinicalTrials.gov Identifier: NCT02569554|
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : May 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: PF-06463922 Drug: rabeprazole||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|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|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
each subject will receive four single doses of PF-06463922 without food, with food, with rabeprazole (without food), and one of the two new formulations without food.
each subject will receive 4 single oral doses of 100 mg PF-06463922 (treatment A: tablets without food; treatment B: tablets with food; treatment C: tablets without food with rabeprazole; treatment D: oral solution without food). There will be at least 10 days washout period between consecutive PF-06463922 single dose.
20 mg daily tablets in the evening for 5 days and Pf-06463922 on the morning of day 6 in treatment C.
Other Name: Pariet
- plasma AUCinf for PF-06463922 [ Time Frame: 3 months ]area under plasma concentration-time profile from time 0 extrapolated to infinite time for PF-06463922
- plasma Cmax for PF-06463922 [ Time Frame: 3 months ]observed maximal plasma PF-06463922 concentration
- plasma AUClast for PF-06463922 [ Time Frame: 3 months ]area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration for PF-06463922
- plasma Tmax for PF-06463922 [ Time Frame: 3 months ]time to the plasma maximal concentration for PF-06463922
- plasma t1/2 for PF-06463922 [ Time Frame: 3 months ]plasma terminal half-life for PF-06463922
- plasma CL/F for PF-06463922 [ Time Frame: 3 months ]apparent clearance for PF-06463922
- plasma Vz/F for PF-06463922 [ Time Frame: 3 months ]apparent volume of distribution for PF-06463922
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569554
|Pfizer Clinical Research Unit|
|Brussels, Belgium, B-1070|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|