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This is an open-label, randomized, cross-over, single dose study in healthy volunteers to evaluate the potential effect of esomeprazole, a proton pump inhibitor, on the pharmacokinetics of crizotinib. Each subject enrolled will receive two single oral doses of crioztinib with or without esomeprazole separated by a washout period of at least 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| crizotinib/crizotinib+esomeprazole crossover | Experimental | Each subject in this study will receive two treatments (A and B) separated by at least 14 days of washout period. Treatment A is a 250 mg single oral dose of crizotinib administered in a fasted state as 1x 250 mg Formulated Capsule. Treatment B consists of 40 mg daily esomeprazole dose from Day 1 to Day 5 and a 250 mg single oral dose of crizotinib administered in a fasted state as 1x 250 mg Formulated Capsule on Day 5. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| crizotinib | Drug | Each subject in Treatment A will receive a 250 mg single oral dose of crizotinib administered in a fasted state as 1x 250 mg Formulated Capsule on Day 1 and each subject in Treatment B will receive a 250 mg single oral dose of crizotinib administered in a fasted state as 1x 250 mg Formulated Capsule on Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma AUCinf [area under the plasma concentration-time profile from time 0 to infinite time] for crizotinib | 2 months | |
| Plasma Cmax [maximum observed concentration] for crizotinib | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma AUClast [area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration] for crizotinib | 2 months | |
| Plasma Tmax [time for maximum observed concentration] for crizotinib | 2 months |
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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 Investigational Site | Brussels | B-1070 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34825782 | Derived | Xu H, O'Gorman M, Matschke K, Boutros T, Brega N, Tan W, Bello A. Evaluation of Proton Pump Inhibitor Esomeprazole on Crizotinib Pharmacokinetics in Healthy Participants. Clin Pharmacol Drug Dev. 2022 Jan;11(1):34-42. doi: 10.1002/cpdd.1032. Epub 2021 Nov 26. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D000077547 | Crizotinib |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000631 | Aminopyridines |
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| esomeprazole | Drug | Each subject in Treatment B will receive 40 mg daily dose of esomeprazole from Day 1 to Day 5 |
|
| Plasma t1/2 [terminal half-life] for crizotinib | 2 months |
| Plasma CL/F [apparent oral clearance] for crizotinib | 2 months |
| Plasma Vz/F [apparent volume of distribution] for crizotinib | 2 months |
| Plasma AUClast for metabolite (PF-06260182) if appropriate | 2 months |
| crizotinib/metabolite AUClast ratio if appropriate | 2 months |
| Plasma AUCinf for metabolite (PF-06260182) if appropriate | 2 months |
| crizotinib/metabolite AUCinf ratio if appropriate | 2 months |
| Plasma Cmax for metabolite (PF-06260182) if appropriate | 2 months |
| crizotinib/metabolite Cmax ratio if appropriate | 2 months |
| Plasma Tmax for metabolite (PF-06260182) if appropriate | 2 months |
| D011725 |
| Pyridines |
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |