A Study To Taste Three New Types Of Crizotinib Formulation In Comparison Of An Oral Solution And To Measure The Amount Of Crizotinib In The Body After These Formulations Are Orally Given, Relative To Capsule Formulation

NCT02006277 ↗

Phase 1 Completed 21 enrolled Pfizer

CrossoverOpen-labelBasic science

Summary

This study is intended to evaluate the sensory attributes and estimate the relative bioavailability of three prototype oral formulations. Subjects will either taste 75-mg doses by "swirl and spit" (Cohort 1) or will receive five oral single 250-mg doses with a washout period of at least 14 days (Cohort 2).

Timeline

Start: 2013-12
Primary completion: 2014-03
Completion: 2014-03

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	75 mg	Oral
Subject	Crizotinib	Small molecule	250 mg	Oral

Indications

No indication recorded.