This study was conducted in healthy subjects and it is required that all trial participants don’t have any medical condition.
Conditions
Interventions
Trade Name: Xalkori
Product Name: Xalkori
Product Code: PF-02341066
Pharmaceutical Form: Granules
INN or Proposed INN: Crizotinib
CAS Number: 877399-52-5
Current Sponsor code: PF-02341066
Other descr
Sponsors
Pfizer, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests. - Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. - Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb). - Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). - Any condition possibly affecting drug absorption (eg, gastrectomy, gastric or intestinal bypass surgery, cholecystectomy). - Any condition possibly affecting the ability to taste (eg, dysgeusia, respiratory infection). - Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever was longer) prior to the first dose of crizotinib. - Participants with history of known sensitivity to esomeprazole or substituted benzimidazoles. - Previous administration with an investigational product within 30 days or 5 half-lives preceding the first dose of crizotinib (whichever was longer). - Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Pharmacokinetics: To estimate the relative bioavailability of 2 new crizotinib formulations (coated microsphere 1 {cMS1} and coated microsphere 2 {cMS2}) to the commercially available crizotinib formulated capsule (FC) at a single 250 mg dose administered under fasted conditions in adult healthy participants. Taste: To evaluate the palatability of crizotinib cMS1 and cMS2 formulations of 250 mg dose in comparison with the crizotinib oral solution (OS) of 250 mg dose in adult healthy participants. ;Secondary Objective: Safety: To assess the safety and tolerability of crizotinib 250 mg single doses in 4 different formulations (cMS1, cMS2, FC and OS) when given fasted, with high fat(HF) meal or with the proton pump inhibitor(PPI), esomeprazole, in adult healthy participants. Pharmacokinetics: To explore the effect of food on the PK of cMS1 and cMS2. To explore the effect of esomeprazole on the PK of cMS1 and cMS2. ;Primary end point(s): Timepoint: 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, and 96 hours post-dose after fasting administration of cMS1, cMS2 and capsule crizotinib Area Under the Curve From Time Zero to Extrapolated Infinite Time Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Maximum Observed Plasma Concentration (Cmax) Timepoint: 1 (immediately after dosing), 5, 10, and 20 minutes after fasting administration of cMS1, cMS2 and OS crizotinib •taste questionnaire score of overall liking of drug formulation •taste questionnaire score of bitterness of drug formulation •taste questionnaire score of mouth feel from drug formulation •taste questionnaire score of tongue/mouth burn from drug formulation •taste questionnaire score of throat burn from drug formulation ;Timepoint(s) of evaluation of this end point: 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, and 96 hours post-dose after fasting administration of cMS1, cMS2 and capsule crizotinib 1 (immediately after dosing), 5, 10, | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Timepoint: From screening to the end of study (safety) Number of subjects and percentage of subjects reporting abnormal safety Laboratory tests, abnormal ECGs, abnormal vital signs and AEs Timepoint: 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, and 96 hours after administration of cMS1, cMS2 with and without food; Timepoint: 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, and 96 hours administration of cMS1, cMS2 after esomeprazole dose; capsule dosing AUCinf AUClast Cmax cMS1, cMS2 with and without food; cMS1, cMS2 after esomeprazole dose; Capsule dosing Time for Cmax (Tmax) Terminal half-life (t1/2) Apparent oral clearance (CL/F) Apparent volume of distribution (Vz/F);Timepoint(s) of evaluation of this end point: From screening to the end of study (safety) Timepoint: 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, and 96 hours after administration of cMS1, cMS2 with and without food; Timepoint: 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, and 96 hours administration of cMS1, cMS2 after esomeprazole dose; capsule dosing | — |
Countries
United States
Contacts
Public ContactClinical Trials.gov Call center
Pfizer, Inc.
Outcome results
None listed