<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/NCT02217787</url>
  </required_header>
  <id_info>
    <org_study_id>B7431008</org_study_id>
    <secondary_id>2014-002967-13</secondary_id>
    <nct_id>NCT02217787</nct_id>
  </id_info>
  <brief_title>Food Effect Study for PF-06372865</brief_title>
  <official_title>A Phase 1, Cross-over, Randomized, Single-dose Open Label Study To Determine The Effect Of Food On The Pharmacokinetics Of Orally Administered Pf-06372865 In Healthy Adult Subjects</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>
      This study has been designed to investigate the effect of high fat food on the&#xD;
      pharmacokinetics of PF-06372865 when administered to healthy subjects as single oral doses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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>basline to 48 hours</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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)</measure>
    <time_frame>basline to 48 hours</time_frame>
    <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>basline to 48 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>basline to 48 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Decay Half-Life (t1/2)</measure>
    <time_frame>basline to 48 hours</time_frame>
    <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Systolic Blood Pressure</measure>
    <time_frame>basline to 48 hours</time_frame>
    <description>Value at time T minus value at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Diastolic Blood Pressure</measure>
    <time_frame>basline to 48 hours</time_frame>
    <description>Value at time T minus value at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in heart rate</measure>
    <time_frame>basline to 48 hours</time_frame>
    <description>value at time T minus value at baseline</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>fasted condition</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>fed condition</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06372865</intervention_name>
    <description>7.5 mg as 3 x 2.5 mg tablets single dose</description>
    <arm_group_label>fasted condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06372865</intervention_name>
    <description>7.5 mg as 3 x 2.5 mg tablets single dose</description>
    <arm_group_label>fed condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and/or female subjects of non-childbearing potential between the ages of&#xD;
             18 and 55 years, inclusive&#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;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or&#xD;
             allergic disease&#xD;
&#xD;
          -  Screening supine blood pressure &gt; 140 mm Hg (systolic) or &gt;90 mm Hg (diastolic),&#xD;
             following at least 5 minutes of supine rest.&#xD;
&#xD;
          -  Any condition possibly affecting drug absorption: current or recent (within one year)&#xD;
             gastrointestinal disease; a history of malabsorption, esophageal reflux, irritable&#xD;
             bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any&#xD;
             surgical intervention (e.g., cholecysectomy) which would be expected to influence the&#xD;
             absorption of drugs.&#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 Clinical Research Unit</name>
      <address>
        <city>Brussels</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=B7431008&amp;StudyName=Food%20effect%20study%20for%20PF-06372865%20</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>October 24, 2014</last_update_submitted>
  <last_update_submitted_qc>October 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 27, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>PF-06372865</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/NCT02217787
org study id: B7431008
secondary id: 2014-002967-13
nct id: NCT02217787
lead sponsor: 
has dmc: No
This study has been designed to investigate the effect of high fat food on the
      pharmacokinetics of PF-06372865 when administered to healthy subjects as single oral doses.
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: basline to 48 hours
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).
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
time frame: basline to 48 hours
description: Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: basline to 48 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
time frame: basline to 48 hours
measure: Plasma Decay Half-Life (t1/2)
time frame: basline to 48 hours
description: Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
measure: Change from Baseline in Systolic Blood Pressure
time frame: basline to 48 hours
description: Value at time T minus value at baseline.
measure: Change from Baseline in Diastolic Blood Pressure
time frame: basline to 48 hours
description: Value at time T minus value at baseline.
measure: Change from baseline in heart rate
time frame: basline to 48 hours
description: value at time T minus value at baseline
arm group label: fasted condition
arm group type: Other
arm group label: fed condition
arm group type: Other
intervention type: Drug
intervention name: PF-06372865
description: 7.5 mg as 3 x 2.5 mg tablets single dose
arm group label: fasted condition
intervention type: Drug
intervention name: PF-06372865
description: 7.5 mg as 3 x 2.5 mg tablets single dose
arm group label: fed condition
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=B7431008&StudyName=Food%20effect%20study%20for%20PF-06372865%20
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: PF-06372865