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

Pfizer24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

dacomitinib fastedDRUG

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

dacomitinib fedDRUG

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

dacomitinib+antacidDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Brussels, Belgium

Outcomes

Primary Outcomes

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

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

Time frame: 2 weeks

Maximum Observed Plasma Concentration (Cmax)

For dacomitinib and PF-05199265

Time frame: 2 weeks

Secondary Outcomes

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]

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

Time frame: 2 weeks

Area under the Concentration-Time Curve (AUC)

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

Time frame: 3 days

Apparent Oral Clearance (CL/F)

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 frame: 2 weeks

Time to Reach Maximum Observed Plasma Concentration (Tmax)

For dacomitinib and PF-05199265

Time frame: 2 weeks

Data from ClinicalTrials.gov

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