Ignite Creation Date:
2024-05-06 @ 7:37 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02569554
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2015-10-05
Brief Title:
PPI And Food Effect Study For PF-06463922 In Healthy Volunteers
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-003416-21 | EUDRACT_NUMBER | None | None |
| PPI STUDY | OTHER | Alias Study Number | None |