<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/NCT01691274</url>
  </required_header>
  <id_info>
    <org_study_id>B5311002</org_study_id>
    <nct_id>NCT01691274</nct_id>
  </id_info>
  <brief_title>A Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Multiple Oral Doses Of PF-04895162</brief_title>
  <official_title>A Double Blind (3rd Party Open) Randomized, Placebo Controlled, Parallel Group Dose Escalation Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of Pf-04895162 In Healthy 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>
      The purpose of this study in healthy people is to investigate safety, toleration and time&#xD;
      course of plasma concentration of PF-04895162, following multiple oral doses for 14 days. The&#xD;
      preliminary effect of food on Pharmacokinetics (PK) after single oral dose of PF-04895162&#xD;
      will also be investigated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum observed plasma concentration (Cmax)</measure>
    <time_frame>up to 12 h post dose for Days 1, 7 and 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of maximum concentration (Tmax)</measure>
    <time_frame>up to 12 h post dose for Days 1, 7 and 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration time profile from time zero extrapolated to inifinite time (AUCinf)</measure>
    <time_frame>up to 12 h post dose for Days 1, 7 and 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration time profile from time zero to the time of last quantifiable concentration (AUClast)</measure>
    <time_frame>up to 12 h post dose for Days 1, 7 and 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration time profile from time zero to quantifiable concentration 24 h post dose (AUC24)</measure>
    <time_frame>up to 12 h post dose for Days 1, 7 and 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCtau= Area under the curve from the time of dosing to the next dose (ng.hr/mL)</measure>
    <time_frame>up to 12 h post dose for Days 1, 7 and 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>t1/2 = Terminal Elimination half life</measure>
    <time_frame>up to 12 h post dose for Days 1, 7 and 14</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>PF-04895162</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-04895162</intervention_name>
    <description>Tablets, 300 mg, single, 1 day</description>
    <arm_group_label>PF-04895162</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-04895162</intervention_name>
    <description>Tablets, 300 mg, twice a day, 14 days</description>
    <arm_group_label>PF-04895162</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-04895162</intervention_name>
    <description>Tablets, to be decided, twice a day, 14 days</description>
    <arm_group_label>PF-04895162</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tablets, twice a day, 14 days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male and/or female subjects of non-child bearing 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;
          2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight &gt;50 kg (110 lbs).&#xD;
&#xD;
          3. An informed consent document signed and dated by the subject.&#xD;
&#xD;
          4. 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 7 drinks/week for females or 14&#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 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 per local SOP) .&#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;
          -  Use of prescription or nonprescription drugs and dietary supplements within 7 days or&#xD;
             5 half lives (whichever is longer) prior to the first dose of study medication. As an&#xD;
             exception, acetaminophen/paracetamol may be used at doses of &lt;=1 g/day. Limited use of&#xD;
             non prescription medications that are not believed to affect subject safety or the&#xD;
             overall results of the study may be permitted on a case-by-case basis following&#xD;
             approval by the sponsor.&#xD;
&#xD;
          -  Herbal supplements and hormonal methods of contraception (including oral and&#xD;
             transdermal contraceptives, injectable progesterone, progestin subdermal implants,&#xD;
             progesterone-releasing IUDs and postcoital contraceptive methods) and hormone&#xD;
             replacement therapy must be discontinued at least 28 days prior to the first dose of&#xD;
             study medication.&#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;
          -  History of seizure or of a condition with risk of seizures. (A history of 1 febrile&#xD;
             seizure in childhood does not exclude the subject.)&#xD;
&#xD;
          -  Use of tobacco- or nicotine-containing products in excess of the equivalent of 5&#xD;
             cigarettes per day.&#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>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5311002&amp;StudyName=A%20Study%20In%20Healthy%20People%20To%20Evaluate%20Safety%2C%20Toleration%20And%20Time%20Course%20Of%20Plasma%20Concentration%20Of%20Multiple%20Oral%20Doses%20Of%20PF-048951</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>March 26, 2013</last_update_submitted>
  <last_update_submitted_qc>March 26, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 28, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Epilepsy</keyword>
  <keyword>Phase 1</keyword>
  <keyword>Multiple Dose</keyword>
  <keyword>Safety</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Toleration</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/NCT01691274
org study id: B5311002
nct id: NCT01691274
lead sponsor: 
has dmc: No
The purpose of this study in healthy people is to investigate safety, toleration and time
      course of plasma concentration of PF-04895162, following multiple oral doses for 14 days. The
      preliminary effect of food on Pharmacokinetics (PK) after single oral dose of PF-04895162
      will also be investigated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Maximum observed plasma concentration (Cmax)
time frame: up to 12 h post dose for Days 1, 7 and 14
measure: Time of maximum concentration (Tmax)
time frame: up to 12 h post dose for Days 1, 7 and 14
measure: Area under the plasma concentration time profile from time zero extrapolated to inifinite time (AUCinf)
time frame: up to 12 h post dose for Days 1, 7 and 14
measure: Area under the plasma concentration time profile from time zero to the time of last quantifiable concentration (AUClast)
time frame: up to 12 h post dose for Days 1, 7 and 14
measure: Area under the plasma concentration time profile from time zero to quantifiable concentration 24 h post dose (AUC24)
time frame: up to 12 h post dose for Days 1, 7 and 14
measure: AUCtau= Area under the curve from the time of dosing to the next dose (ng.hr/mL)
time frame: up to 12 h post dose for Days 1, 7 and 14
measure: t1/2 = Terminal Elimination half life
time frame: up to 12 h post dose for Days 1, 7 and 14
arm group label: PF-04895162
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: PF-04895162
description: Tablets, 300 mg, single, 1 day
arm group label: PF-04895162
intervention type: Drug
intervention name: PF-04895162
description: Tablets, 300 mg, twice a day, 14 days
arm group label: PF-04895162
intervention type: Drug
intervention name: PF-04895162
description: Tablets, to be decided, twice a day, 14 days
arm group label: PF-04895162
intervention type: Drug
intervention name: Placebo
description: Tablets, twice a day, 14 days
arm group label: Placebo
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: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5311002&StudyName=A%20Study%20In%20Healthy%20People%20To%20Evaluate%20Safety%2C%20Toleration%20And%20Time%20Course%20Of%20Plasma%20Concentration%20Of%20Multiple%20Oral%20Doses%20Of%20PF-048951
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor