Evaluate Taste and Relative Bioavailability of Two Microsphere Formulations of Crizotinib in Healthy Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

June 12, 2019

Primary Completion Date

October 17, 2019

Study Completion Date

October 17, 2019

Conditions
Healthy Volunteers
Interventions
DRUG

Treatment A

Single 250 mg crizotinib dose as coated microsphere 1 (cMS1) formulation will be administered on the morning of Day 1 after an overnight fast of at least 10 hours.

DRUG

Treatment B

A single 250 mg crizotinib dose as coated microsphere 2 (cMS2) formulation will be administered on the morning of Day 1 after overnight fast of at least 10 hours.

DRUG

Treatment C

A single 250 mg crizotinib dose as FC formulation will be administered on the morning of Day 1 after an overnight fast of at least 10 hours.

DRUG

Treatment D

A single 250 mg crizotinib dose as OS will be administered on the morning of Day 1 after an overnight fast of at least 10 hours.

DRUG

Treatment E

250 mg crizotinib as cMS1 formulation will be administered with high-fat, high-calorie meal after an overnight fast of at least 10 hours.

DRUG

Treatment F

250 mg crizotinib as cMS2 will be administered with a high-fat, high-calorie meal after an overnight fast of at least 10 hours.

DRUG

Treatment G

"40 mg esomeprazole will be administered~1 hour prior to dinner on Day -5 through Day -1. A single 250 mg crizotinib dose as cMS1 formulation will be administered on the morning of Day 1 after an overnight fast of at least 10 hours."

DRUG

Treatment H

"40 mg esomeprazole will be administered~1 hour prior to dinner on Day -5 through Day -1. A single 250 mg crizotinib dose as cMS2 formulation will be administered on the morning of Day 1 after an overnight fast of at least 10 hours."

Trial Locations (1)

06511

Pfizer New Haven Clinical Research Unit, New Haven

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY