<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/NCT01706796</url>
  </required_header>
  <id_info>
    <org_study_id>B5261003</org_study_id>
    <nct_id>NCT01706796</nct_id>
  </id_info>
  <brief_title>A Study Comparing PF-06273340 Immediate Release Tablet, PF-06273340 Modified Release Tablets To PF-06273340 Oral Solution In The Fasted State. This Study Will Also Compare PF-06273340 Modified Release Tablets In Fasted And Fed State</brief_title>
  <official_title>A Phase 1, Open Label, Randomized, Single Dose, 5 Period Crossover Relative Bioavailability Study In Healthy Volunteers Evaluating Spray Dried Dispersion (SDD) Immediate Release (IR) PF-06273340 Tablet, Two SDD Modified Release (MR) Matrix Tablets In Comparison With PF-06273340 Oral Solution, Including Preliminary Assessment Of Food Effect</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 PF-06273340 tablets.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>up to 48 h post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)</measure>
    <time_frame>up to 48 h post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]</measure>
    <time_frame>up to 48 h post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Elimination half life</measure>
    <time_frame>up to 48 h post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>up to 48 h post dose</time_frame>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>PF-06273340 Oral Solution Fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-06273340 Immediate Release Tablet Fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-06273340 Modified Release (MR1) Tablet Fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-06273340 Modified Release (MR2) Tablet Fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-06273340 Modified Release (MR1) Tablet Fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-06273340 Modified Release (MR2) Tablet Fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06273340</intervention_name>
    <description>Oral solution, single dose, fasted</description>
    <arm_group_label>PF-06273340 Oral Solution Fasted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06273340</intervention_name>
    <description>Immediate Release Tablet, single dose, fasted</description>
    <arm_group_label>PF-06273340 Immediate Release Tablet Fasted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06273340</intervention_name>
    <description>Modified Release Tablet (short duration, MR1), single dose, fasted</description>
    <arm_group_label>PF-06273340 Modified Release (MR1) Tablet Fasted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06273340</intervention_name>
    <description>Modified Release Tablet (long duration, MR2), single dose, fasted</description>
    <arm_group_label>PF-06273340 Modified Release (MR2) Tablet Fasted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06273340</intervention_name>
    <description>Modified Release Tablet (short duration, MR1), single dose, fed</description>
    <arm_group_label>PF-06273340 Modified Release (MR1) Tablet Fed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06273340</intervention_name>
    <description>Modified Release Tablet (long duration, MR2), single dose, fed</description>
    <arm_group_label>PF-06273340 Modified Release (MR2) Tablet Fed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and/or female subjects of non-child bearing potential, between the ages&#xD;
             of 21 and 55 years, inclusive (Healthy is defined as no clinically relevant&#xD;
             abnormalities identified by a detailed medical history, full physical examination,&#xD;
             including blood pressure and pulse rate measurement, 12-lead ECG and clinical&#xD;
             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;
          -  An informed consent document signed and dated by the subject.&#xD;
&#xD;
          -  Subjects who are willing and able to comply with scheduled visits, treatment plan,&#xD;
             laboratory tests, and other study procedures&#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;
          -  Use of tobacco- or nicotine-containing products in excess of the equivalent of 5&#xD;
             cigarettes per day.&#xD;
&#xD;
          -  Treatment with an investigational drug within 30 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 &gt;=140 mm Hg (systolic) or &gt;=90 mm Hg (diastolic), on a&#xD;
             single measurement (confirmed by a single repeat, if necessary) following at least 5&#xD;
             minutes of rest.&#xD;
&#xD;
          -  Evidence or history of orthostatic hypotension.&#xD;
&#xD;
          -  12-lead ECG demonstrating QTc &gt;450 or a QRS interval &gt;120 msec at Screening. If QTc&#xD;
             exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times&#xD;
             and the average of the three QTc values should be used to determine the subject's&#xD;
             eligibility.&#xD;
&#xD;
          -  Pregnant or nursing females; females of childbearing potential, including those with&#xD;
             tubal ligation.&#xD;
&#xD;
          -  Use of prescription or nonprescription drugs, vitamins and dietary supplements within&#xD;
             7 days or 5 half-lives (whichever is longer) prior to the first dose of study&#xD;
             medication. Herbal supplements must be discontinued 28 days prior to the first dose of&#xD;
             study medication. As an exception, acetaminophen/paracetamol may be used at doses of&#xD;
             &lt;=1 g/day. Limited use of non-prescription medications that are not believed to affect&#xD;
             subject safety or the overall results of the study may be permitted on a case-by-case&#xD;
             basis following approval by the sponsor.&#xD;
&#xD;
          -  Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more&#xD;
             within 56 days prior to dosing.&#xD;
&#xD;
          -  History of sensitivity to heparin or heparin-induced thrombocytopenia.&#xD;
&#xD;
          -  Unwilling or unable to comply with the Lifestyle guidelines described in this&#xD;
             protocol.&#xD;
&#xD;
          -  Other severe acute or chronic medical or psychiatric condition or laboratory&#xD;
             abnormality that may increase the risk associated with study participation or&#xD;
             investigational product administration or may interfere with the interpretation of&#xD;
             study results and, in the judgment of the investigator, would make the subject&#xD;
             inappropriate for entry into this study.&#xD;
&#xD;
          -  Subjects who are investigational site staff members or relatives of those site staff&#xD;
             members or subjects who are Pfizer employees directly involved in the conduct of the&#xD;
             trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 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>Singapore</city>
        <zip>188770</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5261003&amp;StudyName=A%20Study%20Comparing%20PF-06273340%20Immediate%20Release%20Tablet%2C%20PF-06273340%20Modified%20Release%20Tablets%20To%20PF-06273340%20Oral%20Solution%20In%20The%20Fasted%20</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>January 23, 2013</last_update_submitted>
  <last_update_submitted_qc>January 23, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pain</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/NCT01706796
org study id: B5261003
nct id: NCT01706796
lead sponsor: 
has dmc: No
The primary purpose of this study is to estimate the relative bioavailability and food effect
      of PF-06273340 tablets.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: up to 48 h post dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
time frame: up to 48 h post dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
time frame: up to 48 h post dose
measure: Elimination half life
time frame: up to 48 h post dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
time frame: up to 48 h post dose
arm group label: PF-06273340 Oral Solution Fasted
arm group type: Experimental
arm group label: PF-06273340 Immediate Release Tablet Fasted
arm group type: Experimental
arm group label: PF-06273340 Modified Release (MR1) Tablet Fasted
arm group type: Experimental
arm group label: PF-06273340 Modified Release (MR2) Tablet Fasted
arm group type: Experimental
arm group label: PF-06273340 Modified Release (MR1) Tablet Fed
arm group type: Experimental
arm group label: PF-06273340 Modified Release (MR2) Tablet Fed
arm group type: Experimental
intervention type: Drug
intervention name: PF-06273340
description: Oral solution, single dose, fasted
arm group label: PF-06273340 Oral Solution Fasted
intervention type: Drug
intervention name: PF-06273340
description: Immediate Release Tablet, single dose, fasted
arm group label: PF-06273340 Immediate Release Tablet Fasted
intervention type: Drug
intervention name: PF-06273340
description: Modified Release Tablet (short duration, MR1), single dose, fasted
arm group label: PF-06273340 Modified Release (MR1) Tablet Fasted
intervention type: Drug
intervention name: PF-06273340
description: Modified Release Tablet (long duration, MR2), single dose, fasted
arm group label: PF-06273340 Modified Release (MR2) Tablet Fasted
intervention type: Drug
intervention name: PF-06273340
description: Modified Release Tablet (short duration, MR1), single dose, fed
arm group label: PF-06273340 Modified Release (MR1) Tablet Fed
intervention type: Drug
intervention name: PF-06273340
description: Modified Release Tablet (long duration, MR2), single dose, fed
arm group label: PF-06273340 Modified Release (MR2) Tablet Fed
criteria: 
gender: All
minimum age: 21 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
country: Singapore
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5261003&StudyName=A%20Study%20Comparing%20PF-06273340%20Immediate%20Release%20Tablet%2C%20PF-06273340%20Modified%20Release%20Tablets%20To%20PF-06273340%20Oral%20Solution%20In%20The%20Fasted%20
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor