<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/NCT02201511</url>
  </required_header>
  <id_info>
    <org_study_id>B7441006</org_study_id>
    <secondary_id>2014-001214-25</secondary_id>
    <nct_id>NCT02201511</nct_id>
  </id_info>
  <brief_title>A Healthy Volunteer Trial to Gain Information About the Blood Concentrations of PF-06412562 After Oral Administration of a Modified Release Formulation in Fasted and Fed Conditions</brief_title>
  <official_title>A Phase 1, Open-label Study In Healthy Subjects To Investigate the Pharmacokinetics Of Pf-06412562 Following Single Oral Administration Of Modified Release Formulation In Fasted And Fed States</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>
      The study is designed to understand the blood concetration of PF-06412562 and its metabolite,&#xD;
      PF-06663872, following a single oral dose of a modified release formulation. The study will&#xD;
      include two doses of the PF-06412562 modified release formulation to understand the&#xD;
      proportionality. Effect of food on absorption of PF-06412562 from the modified release&#xD;
      formulation will also be investigated in this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 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>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>0-2 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>0-2 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time after dose and before the first plasma concentration (Tlag)</measure>
    <time_frame>0-2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]</measure>
    <time_frame>0- 2 days</time_frame>
    <description>AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0 - t) plus AUC (t - inf).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]</measure>
    <time_frame>0-2 days</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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Decay Half-Life (t1/2)</measure>
    <time_frame>0-2 days</time_frame>
    <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>3 mg PF-06412562 MR tablets_Fasted</intervention_name>
    <description>A single modified release tablet with 3 mg PF-06412562 administered after an overnight fast</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2 x 15 mg PF-06412562 MR tablets_Fasted</intervention_name>
    <description>Two 15 mg PF-06412562 modified release tablets administered after an overnight fast</description>
    <arm_group_label>2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2 x 15 mg PF-06412562 MR tablets_Fed</intervention_name>
    <description>Two 15 mg PF-06412562 modified release tablets administered after a high fat breakfast</description>
    <arm_group_label>3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>10 mg PF-06412562 IR tablets</intervention_name>
    <description>a single immediate release tablet of 10 mg PF-06412562 after an overnight fast</description>
    <arm_group_label>4</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 (Healthy is defined as no clinically relevant abnormalities&#xD;
             identified by a detailed medical history, full physical examination, including blood&#xD;
             pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).&#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 (including drug allergies, but excluding untreated, asymptomatic,&#xD;
             seasonal allergies at time of dosing).&#xD;
&#xD;
          -  A positive urine drug screen.&#xD;
&#xD;
          -  Subjects who have attempted suicide in the past.&#xD;
&#xD;
          -  Subjects who have an unexplained history of sudden death in their family&#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=B7441006&amp;StudyName=A%20healthy%20volunteer%20trial%20to%20gain%20information%20about%20the%20blood%20concentrations%20of%20PF-06412562%20after%20oral%20administration%20of%20a%20modified%20rele</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>November 9, 2015</last_update_submitted>
  <last_update_submitted_qc>November 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>relative bioavailbility</keyword>
  <keyword>food effect</keyword>
  <keyword>pharmacokinetics</keyword>
  <keyword>ALTERATION OF COGNITIVE FUNCTIONS</keyword>
  <!-- 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/NCT02201511
org study id: B7441006
secondary id: 2014-001214-25
nct id: NCT02201511
lead sponsor: 
has dmc: No
The study is designed to understand the blood concetration of PF-06412562 and its metabolite,
      PF-06663872, following a single oral dose of a modified release formulation. The study will
      include two doses of the PF-06412562 modified release formulation to understand the
      proportionality. Effect of food on absorption of PF-06412562 from the modified release
      formulation will also be investigated in this study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: 0-2 days
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
time frame: 0-2 days
measure: Time after dose and before the first plasma concentration (Tlag)
time frame: 0-2
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
time frame: 0- 2 days
description: AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0 - t) plus AUC (t - inf).
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
time frame: 0-2 days
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)
measure: Plasma Decay Half-Life (t1/2)
time frame: 0-2 days
description: Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
arm group label: Arm 1
arm group type: Experimental
arm group label: 2
arm group type: Experimental
arm group label: 3
arm group type: Experimental
arm group label: 4
arm group type: Experimental
intervention type: Drug
intervention name: 3 mg PF-06412562 MR tablets_Fasted
description: A single modified release tablet with 3 mg PF-06412562 administered after an overnight fast
arm group label: Arm 1
intervention type: Drug
intervention name: 2 x 15 mg PF-06412562 MR tablets_Fasted
description: Two 15 mg PF-06412562 modified release tablets administered after an overnight fast
arm group label: 2
intervention type: Drug
intervention name: 2 x 15 mg PF-06412562 MR tablets_Fed
description: Two 15 mg PF-06412562 modified release tablets administered after a high fat breakfast
arm group label: 3
intervention type: Drug
intervention name: 10 mg PF-06412562 IR tablets
description: a single immediate release tablet of 10 mg PF-06412562 after an overnight fast
arm group label: 4
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=B7441006&StudyName=A%20healthy%20volunteer%20trial%20to%20gain%20information%20about%20the%20blood%20concentrations%20of%20PF-06412562%20after%20oral%20administration%20of%20a%20modified%20rele
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor