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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: dacomitinib fed; Drug: dacomitinib fasted; Drug: dacomitinib+antacid

• Registration Number: NCT01702506
• Lead Sponsor: Pfizer

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-04
• Study First Submitted QC: 2012-10-04
• Study First Posted: 2012-10-08
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-16
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fed	dacomitinib fed	Dacomitinib administered under fed conditions
Fasted	dacomitinib fasted	Dacomitinib administered under fasted conditions
Antacid	dacomitinib+antacid	Dacomitinib administered under antacid treatment

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium