<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/NCT02184429</url>
  </required_header>
  <id_info>
    <org_study_id>B7821001</org_study_id>
    <nct_id>NCT02184429</nct_id>
  </id_info>
  <brief_title>A Study To Understand Safety And Plasma Concentrations Of PF-06669571 During And Following The Oral Administration Of Single And Multiple Doses Of PF-06669571 In Healthy Volunteers Under Fasted And Fed Conditions</brief_title>
  <official_title>A Phase 1, Double Blind, Sponsor Open, Placebo Controlled Combined Single And Multiple Ascending Dose Study To Investigate The Safety, Tolerability And Food Effect On Pharmacokinetics Of PF-06669571 Following Oral Doses 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>
      This study is designed to evaluate the safety and plasma concentrations of PF-06669571 in&#xD;
      healthy volunteers following single and multiple ascending doses of PF-06669571. Effect of&#xD;
      food on PF-06669571 plasma concentrations will be be evaluated after a single dose of&#xD;
      PF-06669571. During multiple dose phase, PF-06669571 will be administered daily for 14 days&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>screening,Day 28</time_frame>
    <description>C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of &quot;Yes&quot; on &quot;actual attempt&quot;), preparatory acts toward imminent suicidal behavior (3)(&quot;Yes&quot; on &quot;preparatory acts or behavior&quot;), suicidal ideation (4) (&quot;Yes&quot; on &quot;wish to be dead&quot;, &quot;non-specific active suicidal thoughts&quot;, &quot;active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(&quot;Yes&quot; on &quot;Has subject engaged in non-suicidal self-injurious behavior&quot;).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) after single dose</measure>
    <time_frame>0-Day 5</time_frame>
    <description>Cmax after a single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) after single dose</measure>
    <time_frame>0-Day 5</time_frame>
    <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] after single dose</measure>
    <time_frame>0-Day 5</time_frame>
    <description>AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf) after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) after single dose</measure>
    <time_frame>0-Day 5</time_frame>
    <description>Tmax after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Decay Half-Life (t1/2) after single dose</measure>
    <time_frame>0-Day 5</time_frame>
    <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Oral Clearance (CL/F) after single dose</measure>
    <time_frame>0-Day 5</time_frame>
    <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Volume of Distribution (Vz/F) after single dose</measure>
    <time_frame>0-Day 5</time_frame>
    <description>Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) on Days 1, 7 and 14 after multiple daily dose</measure>
    <time_frame>0-Day 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on days 1,7,14 after multiple daily doses</measure>
    <time_frame>0-Day 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) on days 1,7 14 after multiple daily doses</measure>
    <time_frame>0-Day 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Oral Clearance (CL/F) on day 7 and 14 after multiple daily doses</measure>
    <time_frame>0-Day 18</time_frame>
    <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre dose concentrations (Ctrough) on days 7 and 14 after multiple daily doses</measure>
    <time_frame>0-Day 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Observed Plasma Trough Concentration (Cmin) on days 7 and 14 after multiple daily doses</measure>
    <time_frame>0-Day 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation ratio (Rac) for AUCtau on days 7 and 14 after multiple daily doses</measure>
    <time_frame>0-day 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation ratio (Rac) for Cmax on days 7 and 14 after multiple daily doses</measure>
    <time_frame>0-Day 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Decay Half-Life (t1/2) on day 14 after multiple daily doses</measure>
    <time_frame>0-Day 18</time_frame>
    <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Volume of Distribution (Vz/F) on day 14 after multiple daily doses</measure>
    <time_frame>0-Day 18</time_frame>
    <description>Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal clearance (CLr) on day 14</measure>
    <time_frame>0-Day 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of unchanged drug recovered in urine during the dosing interval (AEtau) on Day 14 after multiple daily doses</measure>
    <time_frame>0-Day 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of dose recovered unchanged in urine during the dosing interval (AEtau%) on Day 14 after multiple daily doses</measure>
    <time_frame>0-Day 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak to Trough ratio at Steady State (PTR)</measure>
    <time_frame>0-Day 18</time_frame>
    <description>Cmax to Cmin ratio at steady state</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Single Ascending Dose-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single ascending doses of PF-06669571 administered to healthy volunteers in a cross over study design</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Ascending Dose-2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single ascending doses of PF-06669571 administered to healthy volunteers in a cross over study design</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Ascending Dose-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily dose of PF-06669571 in healthy volunteers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Ascending Dose-2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily dose of PF-06669571 in healthy volunteers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Ascending Dose-3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily dose of PF-06669571 in healthy volunteers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Ascending Dose-4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily dose of PF-06669571 in healthy volunteers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Ascending Dose-5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily dose of PF-06669571 in healthy volunteers</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06669571</intervention_name>
    <description>Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 0.2 mg 0.4 mg, 0.75 mg, 1.50 mg and placebo</description>
    <arm_group_label>Single Ascending Dose-1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06669571</intervention_name>
    <description>Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 3 mg 6 mg, 10 mg, 3 mg (fed) and placebo</description>
    <arm_group_label>Single Ascending Dose-2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06669571</intervention_name>
    <description>Oral dosing of 0.15 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days</description>
    <arm_group_label>Multiple Ascending Dose-1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06669571</intervention_name>
    <description>Oral dosing of 0.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days</description>
    <arm_group_label>Multiple Ascending Dose-2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06669571</intervention_name>
    <description>Oral dosing of 1.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days. This dose may be reached by a titration scheme</description>
    <arm_group_label>Multiple Ascending Dose-3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06669571</intervention_name>
    <description>Oral dosing of 4.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days. This dose may be reached by a titration scheme</description>
    <arm_group_label>Multiple Ascending Dose-4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06669571</intervention_name>
    <description>Oral dosing of 9.0 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule for 14 days. This dose may be reached by a titration scheme</description>
    <arm_group_label>Multiple Ascending Dose-5</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;
        Female subjects of non-childbearing potential must meet at least one of the following&#xD;
        criteria:&#xD;
&#xD;
          1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at&#xD;
             least 12 consecutive months with no alternative pathological or physiological cause;&#xD;
             and have a serum follicle-stimulating hormone (FSH) level confirming the&#xD;
             post-menopausal state;&#xD;
&#xD;
          2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;&#xD;
&#xD;
          3. Have medically confirmed ovarian failure. All other female subjects (including females&#xD;
             with tubal ligations and females that do NOT have a documented hysterectomy, bilateral&#xD;
             oophorectomy and/or ovarian failure) will be considered to be of childbearing&#xD;
             potential.&#xD;
&#xD;
               -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight &gt;50 kg (110&#xD;
                  lbs).&#xD;
&#xD;
               -  Evidence of a personally signed and dated informed consent document indicating&#xD;
                  that the subject has been informed of all pertinent aspects of the study.&#xD;
&#xD;
               -  Subjects who are willing and able to comply with scheduled visits, treatment&#xD;
                  plan, 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;
          -  Treatment with an investigational drug within 30 days (or as determined by the local&#xD;
             requirement) or 5 half-lives preceding the first dose of study medication (whichever&#xD;
             is longer).&#xD;
&#xD;
          -  Screening supine blood pressure &gt;= 140 mm Hg (systolic) or &gt;=90 mm Hg (diastolic),&#xD;
             following at least 5 minutes of rest. If BP is &gt;=140 mm Hg (systolic) or &gt;=90 mm Hg&#xD;
             (diastolic), repeat per local standard operating procedures (SOP). If orthostatic&#xD;
             changes are present and deemed to be clinically significant by the investigator,&#xD;
             Subject can be excluded.&#xD;
&#xD;
          -  For subjects who answer &quot;Yes&quot; to the Columbia Suicide Severity Rating Scale (C-SSRS)&#xD;
             questions 4 or 5, a risk assessment should be done by a qualified mental health&#xD;
             professional (MHP: a psychiatrist or licensed PhD level clinical psychologist) to&#xD;
             assess whether it is safe for the subject to participate in the study. In addition,&#xD;
             subjects deemed by the investigator to be at significant risk of suicidal or violent&#xD;
             behavior should be excluded.&#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>New Haven Clinical Research Unit</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=B7821001&amp;StudyName=A%20Study%20To%20Understand%20Safety%20And%20Plasma%20Concentrations%20Of%20PF-06669571%20During%20And%20Following%20The%20Oral%20Administration%20Of%20Single%20And%20Multipl</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>September 4, 2018</last_update_submitted>
  <last_update_submitted_qc>September 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>First in human</keyword>
  <keyword>single ascending dose study</keyword>
  <keyword>multiple ascending dose study</keyword>
  <keyword>safety and tolerability</keyword>
  <keyword>pharmacokinetics</keyword>
  <keyword>food effect</keyword>
  <keyword>Parkinson's Disease</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>PF-06669571</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/NCT02184429
org study id: B7821001
nct id: NCT02184429
lead sponsor: 
has dmc: No
This study is designed to evaluate the safety and plasma concentrations of PF-06669571 in
      healthy volunteers following single and multiple ascending doses of PF-06669571. Effect of
      food on PF-06669571 plasma concentrations will be be evaluated after a single dose of
      PF-06669571. During multiple dose phase, PF-06669571 will be administered daily for 14 days
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: screening,Day 28
description: C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").
measure: Maximum Observed Plasma Concentration (Cmax) after single dose
time frame: 0-Day 5
description: Cmax after a single dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) after single dose
time frame: 0-Day 5
description: Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) after single dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] after single dose
time frame: 0-Day 5
description: AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf) after single dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) after single dose
time frame: 0-Day 5
description: Tmax after single dose
measure: Plasma Decay Half-Life (t1/2) after single dose
time frame: 0-Day 5
description: Plasma decay half-life is the time measured for the plasma concentration to decrease by one half after single dose
measure: Apparent Oral Clearance (CL/F) after single dose
time frame: 0-Day 5
description: Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood after single dose
measure: Apparent Volume of Distribution (Vz/F) after single dose
time frame: 0-Day 5
description: Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
measure: Maximum Observed Plasma Concentration (Cmax) on Days 1, 7 and 14 after multiple daily dose
time frame: 0-Day 18
measure: Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on days 1,7,14 after multiple daily doses
time frame: 0-Day 18
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) on days 1,7 14 after multiple daily doses
time frame: 0-Day 18
measure: Apparent Oral Clearance (CL/F) on day 7 and 14 after multiple daily doses
time frame: 0-Day 18
description: Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
measure: Pre dose concentrations (Ctrough) on days 7 and 14 after multiple daily doses
time frame: 0-Day 18
measure: Minimum Observed Plasma Trough Concentration (Cmin) on days 7 and 14 after multiple daily doses
time frame: 0-Day 18
measure: Accumulation ratio (Rac) for AUCtau on days 7 and 14 after multiple daily doses
time frame: 0-day 18
measure: Accumulation ratio (Rac) for Cmax on days 7 and 14 after multiple daily doses
time frame: 0-Day 18
measure: Plasma Decay Half-Life (t1/2) on day 14 after multiple daily doses
time frame: 0-Day 18
description: Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
measure: Apparent Volume of Distribution (Vz/F) on day 14 after multiple daily doses
time frame: 0-Day 18
description: Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
measure: Renal clearance (CLr) on day 14
time frame: 0-Day 18
measure: Amount of unchanged drug recovered in urine during the dosing interval (AEtau) on Day 14 after multiple daily doses
time frame: 0-Day 18
measure: Percent of dose recovered unchanged in urine during the dosing interval (AEtau%) on Day 14 after multiple daily doses
time frame: 0-Day 18
measure: Peak to Trough ratio at Steady State (PTR)
time frame: 0-Day 18
description: Cmax to Cmin ratio at steady state
arm group label: Single Ascending Dose-1
arm group type: Experimental
description: Single ascending doses of PF-06669571 administered to healthy volunteers in a cross over study design
arm group label: Single Ascending Dose-2
arm group type: Experimental
description: Single ascending doses of PF-06669571 administered to healthy volunteers in a cross over study design
arm group label: Multiple Ascending Dose-1
arm group type: Experimental
description: Daily dose of PF-06669571 in healthy volunteers
arm group label: Multiple Ascending Dose-2
arm group type: Experimental
description: Daily dose of PF-06669571 in healthy volunteers
arm group label: Multiple Ascending Dose-3
arm group type: Experimental
description: Daily dose of PF-06669571 in healthy volunteers
arm group label: Multiple Ascending Dose-4
arm group type: Experimental
description: Daily dose of PF-06669571 in healthy volunteers
arm group label: Multiple Ascending Dose-5
arm group type: Experimental
description: Daily dose of PF-06669571 in healthy volunteers
intervention type: Drug
intervention name: PF-06669571
description: Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 0.2 mg 0.4 mg, 0.75 mg, 1.50 mg and placebo
arm group label: Single Ascending Dose-1
intervention type: Drug
intervention name: PF-06669571
description: Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 3 mg 6 mg, 10 mg, 3 mg (fed) and placebo
arm group label: Single Ascending Dose-2
intervention type: Drug
intervention name: PF-06669571
description: Oral dosing of 0.15 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
arm group label: Multiple Ascending Dose-1
intervention type: Drug
intervention name: PF-06669571
description: Oral dosing of 0.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
arm group label: Multiple Ascending Dose-2
intervention type: Drug
intervention name: PF-06669571
description: Oral dosing of 1.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days. This dose may be reached by a titration scheme
arm group label: Multiple Ascending Dose-3
intervention type: Drug
intervention name: PF-06669571
description: Oral dosing of 4.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days. This dose may be reached by a titration scheme
arm group label: Multiple Ascending Dose-4
intervention type: Drug
intervention name: PF-06669571
description: Oral dosing of 9.0 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule for 14 days. This dose may be reached by a titration scheme
arm group label: Multiple Ascending Dose-5
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=B7821001&StudyName=A%20Study%20To%20Understand%20Safety%20And%20Plasma%20Concentrations%20Of%20PF-06669571%20During%20And%20Following%20The%20Oral%20Administration%20Of%20Single%20And%20Multipl
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: PF-06669571