Healthy
Conditions
Keywords
healthy volunteers, taste, bioavailability
Brief summary
This study is intended to evaluate the sensory attributes and estimate the relative bioavailability of three prototype oral formulations. Subjects will either taste 75-mg doses by swirl and spit (Cohort 1) or will receive five oral single 250-mg doses with a washout period of at least 14 days (Cohort 2).
Interventions
DRUGCrizotinib prototype microsphere 0.529 mg/mg
Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.
DRUGcrizotinib prototype microsphere 0.470 mg/mg
Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.
DRUGcrizotinib prototype microsphere 0.420 mg/mg
Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.
DRUGcrizotinib oral solution
Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.
DRUGcrizotinib prototype microsphere 0.529 mg/mg
Subjects will receive a single 250-mg oral dose of crizotinib.
DRUGcrizotinib capsule
Subjects will receive a single 250-mg oral dose of crizotinib.
Sponsors
Pfizer
Study design
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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 rate measurement, 12 lead ECG or clinical laboratory tests. * Female subjects of non child bearing potential must have a Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
Exclusion criteria
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * Pregnant or nursing females; females of childbearing potential. * Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. Limited use of non prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | 3 months | 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). |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] | 3 months | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t) |
| Maximum Observed Plasma Concentration (Cmax) | 3 months | — |
| Overall liking, mouth feel, bitterness, tongue/mouth burn of sensory attributes and formulation preference for Cohort 1 | 3 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 3 months | — |
| Overall liking, bitterness, mouth feel, tongue/mouth burn, throat burn of sensory attributes for Cohort 2. | 3 months | — |
| Plasma Decay Half-Life (t1/2) | 3 months | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
| Apparent Oral Clearance (CL/F) | 3 months | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. |
| Apparent Volume of Distribution (Vz/F) | 3 months | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed |
Countries
Belgium
Outcome results
None listed