<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01702506</url>
  </required_header>
  <id_info>
    <org_study_id>A7471015</org_study_id>
    <nct_id>NCT01702506</nct_id>
  </id_info>
  <brief_title>Evaluation Of The Potential Effect That The Administration Of Food Or Antacid Medication May Have In The Oral Absorption Of Dacomitinib (PF-00299804)</brief_title>
  <official_title>Phase 1 Three Period Crossover Study To Evaluate The Effect Of Food And Antacids On The Pharmacokinetics, Safety &amp; Tolerability Of PF-299,804 In Healthy Volunteers Who Have Received PF-299,804</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of the potential effect that the administration of food or antacid medication may&#xD;
      have in the oral absorption of dacomitinib relative to the administration of dacomitinib in&#xD;
      absence of food or antacid medication&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]</measure>
    <time_frame>2 weeks</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>2 weeks</time_frame>
    <description>For dacomitinib and PF-05199265</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]</measure>
    <time_frame>2 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the Concentration-Time Curve (AUC)</measure>
    <time_frame>3 days</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Oral Clearance (CL/F)</measure>
    <time_frame>2 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>2 weeks</time_frame>
    <description>For dacomitinib and PF-05199265</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Volume of Distribution (Vz/F)</measure>
    <time_frame>2 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Decay Half-Life (t1/2)</measure>
    <time_frame>2 weeks</time_frame>
    <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. For dacomitinib</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dacomitinib administered under fasted conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dacomitinib administered under fed conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Antacid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dacomitinib administered under antacid treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dacomitinib fasted</intervention_name>
    <description>Overnight fasted subjects will receive a single 45 mg dose of dacomitinib</description>
    <arm_group_label>Fasted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dacomitinib fed</intervention_name>
    <description>Subjects will receive a single 45 mg dose of dacomitinib with a high calorie high fat meal</description>
    <arm_group_label>Fed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dacomitinib+antacid</intervention_name>
    <description>Subjects will receive a single 45 mg dose of dacomitinib when there are treated with rabeprazole</description>
    <arm_group_label>Antacid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects including males between the ages of 18 and 55 years. Females of non&#xD;
             childbearing potential .&#xD;
&#xD;
          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight &gt;50 kg (110 lbs).&#xD;
&#xD;
          -  An informed consent document signed and dated by the subject.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any condition possibly affecting drug absorption (eg, gastrectomy).&#xD;
&#xD;
          -  A positive urine drug screen.&#xD;
&#xD;
          -  Treatment with an investigational drug within 30 days (or as determined by the local&#xD;
             requirement) or the appropriate time based on the elimination characteristics of the&#xD;
             study medication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pfizer Investigational Site</name>
      <address>
        <city>Bruxelles</city>
        <zip>B-1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7471015&amp;StudyName=Evaluation%20Of%20The%20Potential%20Effect%20That%20The%20Administration%20Of%20Food%20Or%20Antacid%20Medication%20May%20Have%20In%20The%20Oral%20Absorption%20Of%20Dacomitini</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <last_update_submitted>December 16, 2013</last_update_submitted>
  <last_update_submitted_qc>December 16, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 18, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dacomitinib</keyword>
  <keyword>PF-00299804</keyword>
  <keyword>fed</keyword>
  <keyword>fasted</keyword>
  <keyword>antacid</keyword>
  <keyword>relative Bioavailability</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antacids</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01702506
org study id: A7471015
nct id: NCT01702506
lead sponsor: 
has dmc: No
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
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
time frame: 2 weeks
description: 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
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: 2 weeks
description: For dacomitinib and PF-05199265
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
time frame: 2 weeks
description: 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
measure: Area under the Concentration-Time Curve (AUC)
time frame: 3 days
description: 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
measure: Apparent Oral Clearance (CL/F)
time frame: 2 weeks
description: 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
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
time frame: 2 weeks
description: For dacomitinib and PF-05199265
measure: Apparent Volume of Distribution (Vz/F)
time frame: 2 weeks
description: 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
measure: Plasma Decay Half-Life (t1/2)
time frame: 2 weeks
description: Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. For dacomitinib
arm group label: Fasted
arm group type: Experimental
description: Dacomitinib administered under fasted conditions
arm group label: Fed
arm group type: Experimental
description: Dacomitinib administered under fed conditions
arm group label: Antacid
arm group type: Experimental
description: Dacomitinib administered under antacid treatment
intervention type: Drug
intervention name: dacomitinib fasted
description: Overnight fasted subjects will receive a single 45 mg dose of dacomitinib
arm group label: Fasted
intervention type: Drug
intervention name: dacomitinib fed
description: Subjects will receive a single 45 mg dose of dacomitinib with a high calorie high fat meal
arm group label: Fed
intervention type: Drug
intervention name: dacomitinib+antacid
description: Subjects will receive a single 45 mg dose of dacomitinib when there are treated with rabeprazole
arm group label: Antacid
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
country: Belgium
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7471015&StudyName=Evaluation%20Of%20The%20Potential%20Effect%20That%20The%20Administration%20Of%20Food%20Or%20Antacid%20Medication%20May%20Have%20In%20The%20Oral%20Absorption%20Of%20Dacomitini
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Antacids