Phase 1
Completed N=36
Bioequivalence And Food Effect Study Comparing The Commercial Formulation Of Crizotinib To Its Clinical Study Formulations And Commercial Formulation With Or Without Food In Healthy Volunteers
Healthy
Source: ClinicalTrials.gov NCT01154218 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcomePrimary: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) — 2890.0; 2665.0; 2887.0; 2475.0 ng*hr/mL
Summary
The purpose of this study is to demonstrate bioequivalence of the Commercial Image Capsule (CIC) relative to the Immediate Release Tablet (IRT) of crizotinib, bioequivalence of CIC relative to Powder in Capsule (PIC) of crizotinib, and lack of an effect of high fat meal on the pharmacokinetics (PK) of crizotinib when administered as CIC Formulation in healthy volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) |
2890.0; 2665.0; 2887.0; 2475.0 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
126.00; 119.30; 135.00; 116.10 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
2763.0; 2531.0; 2761.0; 2359.0 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
5.00; 5.00; 5.00; 5.00 | — |
| SECONDARY Plasma Decay Half Life (t1/2) |
34.62; 35.28; 34.85; 35.41 | — |
| SECONDARY Apparent Oral Clearance (CL/F) |
86.49; 93.78; 86.57; 101.00 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) |
4290.0; 4703.0; 4313.0; 5096.0 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182) |
432.20; 391.20; 436.90; 325.00 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) for Crizotinib Metabolite (PF-06260182) |
442.00; 402.10; 447.10; 341.80 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182) |
32.20; 29.74; 33.04; 23.64 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182) |
6.00; 6.00; 5.00; 6.00 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male and/or female of non-childbearing potential subjects 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 rate measurement, 12-lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs)
Exclusion Criteria
- Subjects who are smoking, or with evidence of disease, conditions affecting absorption, treatment with other investigational drug within 30 days, history of regular alcohol consumption, use of prescription, nonprescription drugs and dietary supplement within 7 days, or blood donation of 500 mL within 56 days.
Data sourced from ClinicalTrials.gov (NCT01154218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.