Evaluation Of The Potential Effect That The Administration Of Food Or Antacid Medication May Have In The Oral Absorption Of Dacomitinib (PF-00299804)

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01702506

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: dacomitinib fasted Drug: dacomitinib fed Drug: dacomitinib+antacid	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Phase 1 Three Period Crossover Study To Evaluate The Effect Of Food And Antacids On The Pharmacokinetics, Safety & Tolerability Of PF-299,804 In Healthy Volunteers Who Have Received PF-299,804

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fasted Dacomitinib administered under fasted conditions	Drug: dacomitinib fasted Overnight fasted subjects will receive a single 45 mg dose of dacomitinib
Experimental: Fed Dacomitinib administered under fed conditions	Drug: dacomitinib fed Subjects will receive a single 45 mg dose of dacomitinib with a high calorie high fat meal
Experimental: Antacid Dacomitinib administered under antacid treatment	Drug: dacomitinib+antacid Subjects will receive a single 45 mg dose of dacomitinib when there are treated with rabeprazole

Arm

Intervention/Treatment

Experimental: Fasted

Dacomitinib administered under fasted conditions

Drug: dacomitinib fasted

Overnight fasted subjects will receive a single 45 mg dose of dacomitinib

Experimental: Fed

Dacomitinib administered under fed conditions

Drug: dacomitinib fed

Subjects will receive a single 45 mg dose of dacomitinib with a high calorie high fat meal

Experimental: Antacid

Dacomitinib administered under antacid treatment

Drug: dacomitinib+antacid

Subjects will receive a single 45 mg dose of dacomitinib when there are treated with rabeprazole

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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.