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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003416-21 | EudraCT Number | ||
| PPI STUDY | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06463922 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06463922 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| plasma AUCinf for PF-06463922 | area under plasma concentration-time profile from time 0 extrapolated to infinite time for PF-06463922 | 3 months |
| plasma Cmax for PF-06463922 | observed maximal plasma PF-06463922 concentration | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| plasma AUClast for PF-06463922 | area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration for PF-06463922 | 3 months |
| plasma Tmax for PF-06463922 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit | Brussels | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| C000590786 | lorlatinib |
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| rabeprazole | Drug | 20 mg daily tablets in the evening for 5 days and Pf-06463922 on the morning of day 6 in treatment C. |
|
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time to the plasma maximal concentration for PF-06463922
| 3 months |
| plasma t1/2 for PF-06463922 | plasma terminal half-life for PF-06463922 | 3 months |
| plasma CL/F for PF-06463922 | apparent clearance for PF-06463922 | 3 months |
| plasma Vz/F for PF-06463922 | apparent volume of distribution for PF-06463922 | 3 months |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |