<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/NCT01690351</url>
  </required_header>
  <id_info>
    <org_study_id>B3291015</org_study_id>
    <nct_id>NCT01690351</nct_id>
  </id_info>
  <brief_title>A Study Comparing PF-05089771 TS Capsule To PF-05089771 TS Oral Dispersion In The Fasted State</brief_title>
  <official_title>A Phase 1, Open Label, Single Dose, Bioavailability Study In Healthy Volunteers Comparing PF-05089771 TS Oral Dispersion To PF-05089771 TS Capsule</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 primary purpose of this study is to estimate the relative bioavailability and food effect&#xD;
      of a PF-05089771 capsule.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL)</measure>
    <time_frame>days 1-2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUClast = Area under the curve from the time of dosing to the last data point taken (ng.hr/mL)</measure>
    <time_frame>days 1-2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL)</measure>
    <time_frame>days 1-2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax = Time of maximum concentration of PF-05089771 in plasma (hr)</measure>
    <time_frame>days 1-2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>t½ = Elimination half life of PF-05089771 (hr)</measure>
    <time_frame>days 1-2</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>evaluation of safety clinical laboratory tests, vital signs, ECGs, physical examinations and adverse event monitoring.</measure>
    <time_frame>days 1-2</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>PF-05089771 Oral Dispersion fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral dispersion TS formulation- fasted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-05089771 TS formulation fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsules TS formulation- fasted</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-05089771</intervention_name>
    <description>Oral dispersion TS formulation- fasted</description>
    <arm_group_label>PF-05089771 Oral Dispersion fasted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-05089771</intervention_name>
    <description>Capsules TS formulation- fasted</description>
    <arm_group_label>PF-05089771 TS formulation fasted</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and/or non-childbearing potential female subjects between the ages of 18&#xD;
             and 55 years&#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;
          -  Any condition possibly affecting drug absorption (eg, gastrectomy).&#xD;
&#xD;
          -  A positive urine drug screen.&#xD;
&#xD;
          -  History of regular alcohol consumption exceeding 14 drinks/week for females or 21&#xD;
             drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of&#xD;
             beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.&#xD;
&#xD;
          -  Treatment with an investigational drug within 60 days (or as determined by the local&#xD;
             requirement, whichever is longer) or 5 half-lives preceding the first dose of study&#xD;
             medication.&#xD;
&#xD;
          -  Screening supine blood pressure ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), on a&#xD;
             single measurement (confirmed by a single repeat, if necessary) following at least 5&#xD;
             minutes of rest 7. Single 12-lead ECG demonstrating QTc &gt;450 msec or a QRS interval&#xD;
             &gt;120 mseca at screening. If QTc exceeds 450 msec, or QRS exceeds &gt;120 mseca the ECG&#xD;
             should be repeated two more times and the average of the three QTc or QRS values&#xD;
             should be used to determine the subject's eligibility.&#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=B3291015&amp;StudyName=A%20Study%20Comparing%20PF-05089771%20TS%20Capsule%20To%20PF-05089771%20TS%20Oral%20Dispersion%20In%20The%20Fasted%20State%20</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>December 10, 2012</last_update_submitted>
  <last_update_submitted_qc>December 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01690351
org study id: B3291015
nct id: NCT01690351
lead sponsor: 
has dmc: No
The primary purpose of this study is to estimate the relative bioavailability and food effect
      of a PF-05089771 capsule.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL)
time frame: days 1-2
measure: AUClast = Area under the curve from the time of dosing to the last data point taken (ng.hr/mL)
time frame: days 1-2
measure: AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL)
time frame: days 1-2
measure: Tmax = Time of maximum concentration of PF-05089771 in plasma (hr)
time frame: days 1-2
measure: t½ = Elimination half life of PF-05089771 (hr)
time frame: days 1-2
measure: evaluation of safety clinical laboratory tests, vital signs, ECGs, physical examinations and adverse event monitoring.
time frame: days 1-2
arm group label: PF-05089771 Oral Dispersion fasted
arm group type: Experimental
description: Oral dispersion TS formulation- fasted
arm group label: PF-05089771 TS formulation fasted
arm group type: Experimental
description: Capsules TS formulation- fasted
intervention type: Drug
intervention name: PF-05089771
description: Oral dispersion TS formulation- fasted
arm group label: PF-05089771 Oral Dispersion fasted
intervention type: Drug
intervention name: PF-05089771
description: Capsules TS formulation- fasted
arm group label: PF-05089771 TS formulation fasted
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=B3291015&StudyName=A%20Study%20Comparing%20PF-05089771%20TS%20Capsule%20To%20PF-05089771%20TS%20Oral%20Dispersion%20In%20The%20Fasted%20State%20
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor