Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 ...