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Crizotinib prototype microsphere/mg · 1 trial · 1 indication
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Cohort 1 will be an open label, randomized, 4 period, 4 treatment, 4 sequence, cross over sensory evaluation of three new prototype formulations (75 mg dose of crizotinib as prototypes 0.529 mg/mg, 0.470 mg/mg and 0.420 mg/mg Microspheres) and OS (75 mg dose of crizotinib)via use of a Crizotinib Taste Assessment - Questionnaire for Cohort 1 in healthy adults. |
| Cohort 2 | EXPERIMENTAL | This cohort will be an open label, randomized, 5 period, 5 treatment, 4 sequence, cross over single dose bioavailability study employing administration of four crizotinib formulations Treatments E, F, G and H (Crizotinib 250 mg dose Formulated Capsule and 250 mg dose crizotinib as prototypes 0.529 mg/mg, 0.470 mg/mg and 0.420 mg/mg Microspheres, respectively) in the fasted state to healthy adult subjects (Periods 1-4). In addition, Treatment I (250 mg dose of crizotinib OS) will be administered at Period 5, for a taste evaluation only (no pharmacokinetic (PK) sample collection after the dose), in the period immediately following the completion of Period 4 of Cohort 2. A Crizotinib Taste Assessment - Questionnaire for Cohort 2 will be filled by all subjects. |
| Name | Type | Description |
|---|---|---|
| Crizotinib prototype microsphere 0.529 mg/mg | DRUG | Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup. |
| crizotinib prototype microsphere 0.470 mg/mg | DRUG | Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup. |
| crizotinib prototype microsphere 0.420 mg/mg | DRUG | Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup. |
| crizotinib oral solution | DRUG | Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup. |
| crizotinib capsule | DRUG | Subjects will receive a single 250-mg oral dose of crizotinib. |
Inclusion Criteria: * Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse ...
Crizotinib prototype microsphere/mg is an experimental microsphere formulation of crizotinib, a small molecule kinase inhibitor developed by Pfizer, Inc. (ticker PFE). It is a prototype dosage form studied in healthy volunteers rather than a marketed product, and it has been evaluated in a single Phase 1 trial.
Crizotinib prototype microsphere/mg targets ALK, EML4, NPM1, MET, MST1R, and ROS1. It is classified as an inhibitor, meaning it acts on these kinase targets. The microsphere formulation is designed to deliver crizotinib, the same active small molecule, through an alternative dosage form.
Pfizer, Inc. is the developer of Crizotinib prototype microsphere/mg. Pfizer trades on the New York Stock Exchange under the ticker PFE. The compound is a prototype microsphere formulation of crizotinib, Pfizer's small molecule kinase inhibitor.
Crizotinib prototype microsphere/mg is in Phase 1 development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, with no active trials ongoing, and the trial enrolled 21 participants.
Crizotinib prototype microsphere/mg has been studied in one completed Phase 1 trial, NCT02006277. That trial compared three new crizotinib formulations against an oral solution and measured crizotinib levels in the body after oral dosing relative to the capsule formulation. It enrolled 21 healthy volunteers in Belgium.