<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/NCT02260947</url>
  </required_header>
  <id_info>
    <org_study_id>B5261005</org_study_id>
    <secondary_id>2014-003553-34</secondary_id>
    <nct_id>NCT02260947</nct_id>
  </id_info>
  <brief_title>Assessment of the Analgesic Effects of PF-06273340 in Healthy Volunteers Using Evoked Pain Endpoints</brief_title>
  <official_title>A Double Blind, Double Dummy, Randomized, Placebocontrolled, 5 Period Cross-over Study To Examine The Effect of Pf-06273340 On Evoked Pain Endpoints In Healthy Volunteers Using Pregabalin And Ibuprofen As Positive Controls</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 will examine the activity of 2 different doses of PF-06273340 on a panel of evoked&#xD;
      pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Thermal pain detection threshold</measure>
    <time_frame>0.5 - 4 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ultra-violet light sensitized pain detection threshold</measure>
    <time_frame>0.5 - 4 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pressure pain tolerance threshold</measure>
    <time_frame>0.5 - 4 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Electrical pain tolerance threshold</measure>
    <time_frame>0.5 - 4 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cold pressor tolerance threshold</measure>
    <time_frame>0.5 - 4 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrical pain detection threshold</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrical pain area under the visual analogue scale pain curve</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrical pain post test visual analogue scale</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrical pain post-cold pressor pain detection threshold</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrical pain post cold pressor pain tolerance threshold</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrical pain post cold pressor area under the visual analogue scale curve</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrical pain post cold pressor post test visual analogue scale</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conditioned pain modulation response pain detection threshold</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conditioned pain modulation pain tolerance threshold</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conditioned pain modulation area under the visual analogue scale curve</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Condition pain modulation post test VAS</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure pain detection threshold</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure pain area under the visual analogue scale curve</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure pain post test visual analogue scale</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cold pressor pain detection threshold</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cold pressor area under the visual analogue scale curve</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cold pressor post test visual analogue scale</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PF-06273340 half life</measure>
    <time_frame>0.5 - 10 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>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>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>5</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06273340</intervention_name>
    <description>PF-06273340 50 mg</description>
    <arm_group_label>1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06273340</intervention_name>
    <description>PF-06273340 400 mg</description>
    <arm_group_label>2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pregabalin</intervention_name>
    <description>Pregabalin 300 mg</description>
    <arm_group_label>3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen</intervention_name>
    <description>Ibuprofen 600 mg</description>
    <arm_group_label>4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching Placebo</description>
    <arm_group_label>5</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subjects between the ages of 18 and 55 years, inclusive. Healthy is&#xD;
             defined as no clinically relevant abnormalities identified by a detailed medical&#xD;
             history, full physical examination, including blood pressure and pulse rate&#xD;
             measurement, 12 lead ECG or 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;
          -  Evidence of a personally signed and dated informed consent document indicating that&#xD;
             the subject has been informed of all pertinent aspects of the study.&#xD;
&#xD;
          -  Subjects who are willing and able to comply with all 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 the time of dosing).&#xD;
&#xD;
          -  Any condition possibly affecting drug absorption (eg, gastrectomy).&#xD;
&#xD;
          -  A positive urine drug screen&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>Centre for Human Drug Research</name>
      <address>
        <city>Leiden</city>
        <state>CL</state>
        <zip>2333</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>February 2, 2015</last_update_submitted>
  <last_update_submitted_qc>February 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 4, 2015</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>Ibuprofen</mesh_term>
    <mesh_term>Pregabalin</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/NCT02260947
org study id: B5261005
secondary id: 2014-003553-34
nct id: NCT02260947
lead sponsor: 
has dmc: No
This study will examine the activity of 2 different doses of PF-06273340 on a panel of evoked
      pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Thermal pain detection threshold
time frame: 0.5 - 4 hours
measure: Ultra-violet light sensitized pain detection threshold
time frame: 0.5 - 4 hours
measure: Pressure pain tolerance threshold
time frame: 0.5 - 4 hours
measure: Electrical pain tolerance threshold
time frame: 0.5 - 4 hours
measure: Cold pressor tolerance threshold
time frame: 0.5 - 4 hours
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: 0.5 - 10 hours
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
time frame: 0.5 - 10 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
time frame: 0.5 - 10 hours
measure: Electrical pain detection threshold
time frame: 0.5 - 10 hours
measure: Electrical pain area under the visual analogue scale pain curve
time frame: 0.5 - 10 hours
measure: Electrical pain post test visual analogue scale
time frame: 0.5 - 10 hours
measure: Electrical pain post-cold pressor pain detection threshold
time frame: 0.5 - 10 hours
measure: Electrical pain post cold pressor pain tolerance threshold
time frame: 0.5 - 10 hours
measure: Electrical pain post cold pressor area under the visual analogue scale curve
time frame: 0.5 - 10 hours
measure: Electrical pain post cold pressor post test visual analogue scale
time frame: 0.5 - 10 hours
measure: Conditioned pain modulation response pain detection threshold
time frame: 0.5 - 10 hours
measure: Conditioned pain modulation pain tolerance threshold
time frame: 0.5 - 10 hours
measure: Conditioned pain modulation area under the visual analogue scale curve
time frame: 0.5 - 10 hours
measure: Condition pain modulation post test VAS
time frame: 0.5 - 10 hours
measure: Pressure pain detection threshold
time frame: 0.5 - 10 hours
measure: Pressure pain area under the visual analogue scale curve
time frame: 0.5 - 10 hours
measure: Pressure pain post test visual analogue scale
time frame: 0.5 - 10 hours
measure: Cold pressor pain detection threshold
time frame: 0.5 - 10 hours
measure: Cold pressor area under the visual analogue scale curve
time frame: 0.5 - 10 hours
measure: Cold pressor post test visual analogue scale
time frame: 0.5 - 10 hours
measure: PF-06273340 half life
time frame: 0.5 - 10 hours
arm group label: 1
arm group type: Experimental
arm group label: 2
arm group type: Experimental
arm group label: 3
arm group type: Active Comparator
arm group label: 4
arm group type: Active Comparator
arm group label: 5
arm group type: Placebo Comparator
intervention type: Drug
intervention name: PF-06273340
description: PF-06273340 50 mg
arm group label: 1
intervention type: Drug
intervention name: PF-06273340
description: PF-06273340 400 mg
arm group label: 2
intervention type: Drug
intervention name: Pregabalin
description: Pregabalin 300 mg
arm group label: 3
intervention type: Drug
intervention name: Ibuprofen
description: Ibuprofen 600 mg
arm group label: 4
intervention type: Drug
intervention name: Placebo
description: Matching Placebo
arm group label: 5
criteria: 
gender: Male
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: Netherlands
responsible party type: Sponsor
mesh term: Ibuprofen
mesh term: Pregabalin