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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01702506
First received: October 4, 2012
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: dacomitinib fasted
Drug: dacomitinib fed
Drug: dacomitinib+antacid
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    For dacomitinib and PF-05199265


Secondary Outcome Measures:
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    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) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    For dacomitinib and PF-05199265

  • Apparent Volume of Distribution (Vz/F) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. For dacomitinib


Enrollment: 24
Study Start Date: October 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702506

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01702506     History of Changes
Other Study ID Numbers: A7471015
Study First Received: October 4, 2012
Last Updated: December 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Dacomitinib
PF-00299804
fed
fasted
antacid
relative Bioavailability

Additional relevant MeSH terms:
Antacids
Anti-Ulcer Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014