Healthy Volunteers
Conditions
Keywords
Dacomitinib, PF-00299804, fed, fasted, antacid, relative Bioavailability
Brief summary
Evaluation of the potential effect that the administration of food or antacid medication may have in the oral absorption of dacomitinib relative to the administration of dacomitinib in absence of food or antacid medication
Interventions
DRUGdacomitinib fasted
Overnight fasted subjects will receive a single 45 mg dose of dacomitinib
DRUGdacomitinib fed
Subjects will receive a single 45 mg dose of dacomitinib with a high calorie high fat meal
DRUGdacomitinib+antacid
Subjects will receive a single 45 mg dose of dacomitinib when there are treated with rabeprazole
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
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 subjects including males between the ages of 18 and 55 years. Females of non childbearing potential . * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * An informed consent document signed and dated by the subject.
Exclusion criteria
* Any condition possibly affecting drug absorption (eg, gastrectomy). * A positive urine drug screen. * Treatment with an investigational drug within 30 days (or as determined by the local requirement) or the appropriate time based on the elimination characteristics of the study medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | 2 weeks | 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). For dacomitinib and PF-05199265 |
| Maximum Observed Plasma Concentration (Cmax) | 2 weeks | For dacomitinib and PF-05199265 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Oral Clearance (CL/F) | 2 weeks | 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. For dacomitinib |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 2 weeks | For dacomitinib and PF-05199265 |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] | 2 weeks | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).For dacomitinib and PF-05199265 |
| Plasma Decay Half-Life (t1/2) | 2 weeks | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. For dacomitinib |
| Apparent Volume of Distribution (Vz/F) | 2 weeks | 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. For dacomitinib |
| Area under the Concentration-Time Curve (AUC) | 3 days | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. For dacomitinib and PF-05199265 |
Countries
Belgium
Outcome results
None listed