PPI And Food Effect Study For PF-06463922 In Healthy Volunteers
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 explore the relative bioavailability of PF-06463922 oral solution and new tablet formulation to the tablet formulation used in clinical studies.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||A Phase 1, Randomized, Crossover, Open-Label, 4 Period Study In Healthy Volunteers To Estimate The Effect Of Rabeprazole And Food On The Pharmacokinetics Of PF-06463922 With Additional Preliminary Evaluations Of PF-06463922 Oral Solution Formulation And New Free Base Tablet Formulation|
- plasma AUCinf for PF-06463922 [ Time Frame: 3 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]observed maximal plasma PF-06463922 concentration
- plasma AUClast for PF-06463922 [ Time Frame: 3 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]time to the plasma maximal concentration for PF-06463922
- plasma t1/2 for PF-06463922 [ Time Frame: 3 months ] [ Designated as safety issue: No ]plasma terminal half-life for PF-06463922
- plasma CL/F for PF-06463922 [ Time Frame: 3 months ] [ Designated as safety issue: No ]apparent clearance for PF-06463922
- plasma Vz/F for PF-06463922 [ Time Frame: 3 months ] [ Designated as safety issue: No ]apparent volume of distribution for PF-06463922
|Study Start Date:||November 2015|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
each subject will receive four single doses of PF-06463922 without food, with food, with Pariet (without food), and one of the two new formulations without food.
each subject will receive 3 single oral doses of 100 mg PF-06463922 (treatment A: Free Base Tablets containing dry-milled API without food; treatment B: Free Base Tablets containing dry-milled API with food; Treatment C: Free Base Tablets containing dry-milled API without food with rabeprazole). each subject will also receive a single dose of 100 mg PF-06463922 oral solution or PF-066463922 Free Base Tablets containing HSWM API without food. there will be at least 10 days washout period between consecutive PF-06463922 single dose.Drug: rabeprazole
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
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 will be conducted in healthy adult subjects who will receive four single doses of 100 mg PF-06463922 alone, with food, or with rabeprazole, after overnight fasting with at least a 10 day washout period between each PF-06463922 dose. This will be a Phase 1, randomized, open label, 4 period, 5 treatment, 6 sequence, crossover study employing administration of single oral doses of PF-06463922 without food, with food, or with rabeprazole (without food), and two alternative formulations of PF-06463922 (without food).
Twenty four (24) subjects will be enrolled to obtain at least 18 evaluable subjects who complete treatments A, B and C. Each subject will receive three treatments (A, B and C) with a washout period of at least 10 days between each PF-06463922 dose in first 3 study periods. In study Period 4, 12 subjects (half of the total 24) will receive treatment D and the other 12 subjects will receive treatment E. Subjects who withdraw will not be replaced unless the number of completed subjects falls below 3 per sequence in treatments A, B or C.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02569554
|Contact: Pfizer CT.gov Call Center||1-800-718-1021|
|Brussel CRU||Not yet recruiting|
|Brussels, Belgium, 1070|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|