A Study to Evaluate the Effects of Food and Esomeprazole on the Pharmacokinetics of Crizotinib in a Coated Microsphere Formulation.

Phase 1 Completed 18 enrolled Pfizer

RandomizedCrossoverOpen-labelBasic science

Summary

This study will estimate the effect of food and the proton pump inhibitor, esomeprazole on the pharmacokinetics of crizotinib in a coated microsphere formulation.

Timeline

Start: 2017-06-20
Primary completion: 2017-09-19
Completion: 2017-10-17

Publications

Bartlett JA, Culver N, Santangelo M, Prpich A, Long E, Sagawa K, Shanker R, Xu H, Wilner K. Development of a Taste-Masked, Dose-Flexible, Multiparticulate Pediatric Dosage Form: Case Study of Crizotinib, a Challenging Pediatric Formulation. Pharmaceut Med. 2026 May;40(3):193-207. doi: 10.1007/s40290-026-00604-2. Epub 2026 Apr 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Crizotinib	Small molecule	300 mg	Oral
Subject	Esomeprazole	Small molecule	40 mg	—

Indications

No indication recorded.