<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/NCT02224651</url>
  </required_header>
  <id_info>
    <org_study_id>B7921001</org_study_id>
    <secondary_id>IRAK4 FIH</secondary_id>
    <nct_id>NCT02224651</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Safety and Tolerability of Single Ascending Doses of Multiple Formulations of PF-06650833 in Healthy Subjects Under Fasted and Fed Conditions</brief_title>
  <official_title>A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Substitution, Crossover, Single Dose Escalation Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Pf 06650833 Delivered In Multiple Formulations In Healthy Subjects Under Fasted And Fed Conditions</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 single ascending dose study is the first evaluation of PF-06650833 in humans. The goals&#xD;
      are to assess the safety, tolerability and blood levels of ascending doses of multiple&#xD;
      formulations of PF-06650833 and to perform a preliminary assessment of the effect of food on&#xD;
      exposure, in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events</measure>
    <time_frame>Baseline-5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in vital signs ( blood pressure, pulse rate, respiratory rate and orthostatic blood pressure)</measure>
    <time_frame>Baseline-5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in ECG parameters (standard 12 lead ECG and telemetry)</measure>
    <time_frame>Baseline-5 days</time_frame>
    <description>Quantitative changes in ECG intervals</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology, chemistry (including, cardiac enzymes CK, CK MB and cardiac Troponin I), serum myoglobin, urinalysis</measure>
    <time_frame>Baseline-5 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, Cmax(dn), AUCinf(dn), AUClast(dn), t½, mean residence time (MRT) for IR and MR formulations under fasted condition</measure>
    <time_frame>Baseline-5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, Cmax(dn), AUCinf(dn), AUClast(dn), t½, mean residence time (MRT) for IR and MR formulations under fed condition</measure>
    <time_frame>Baseline-5 days</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>(1-1000mg) Immediate Release formulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Immediate Release Placebo arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>(10-500) mg Modified Release formulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Modified Release Placebo arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06650833</intervention_name>
    <description>Subjects will receive sequential single escalating doses of 1-1000 mg of Immediate Release of PF-06650833 (as solution/suspension) under fed and / or fasted conditions.</description>
    <arm_group_label>(1-1000mg) Immediate Release formulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subjects will receive sequential single escalating doses of PF-06650833 matching placebo (as solution/suspension) under fed and/ or fasted conditions.</description>
    <arm_group_label>Immediate Release Placebo arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06650833</intervention_name>
    <description>Subjects will receive sequential single escalating doses of 10-500 mg of Modified Release of PF-06650833 (as capsule) under fed and / or fasted conditions.</description>
    <arm_group_label>(10-500) mg Modified Release formulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subjects will receive sequential single escalating doses of PF-06650833 matching placebo (as capsule) under fed and/ or fasted conditions.</description>
    <arm_group_label>Modified Release Placebo arm</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.&#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;
        Exclusion Criteria:&#xD;
&#xD;
          -  Screening supine blood pressure 100 mm Hg (systolic) or 50 mm Hg (diastolic); or 140&#xD;
             mm Hg (systolic) or 90 mm Hg (diastolic) following at least 5 minutes of supine rest.&#xD;
             If blood pressure (BP) is 140 mm Hg (systolic) or 90 mm Hg (diastolic), the BP should&#xD;
             be repeated two more times and the average of the three BP values should be used to&#xD;
             determine the subject's eligibility.&#xD;
&#xD;
          -  Pulse or heart rate (HR) &gt;100 bpm after at least 5 minutes of rest. If the pulse/HR is&#xD;
             &gt;100 bpm, the pulse/HR should be repeated two more times (separated by at least 2&#xD;
             minutes) and the average of the three pulse/HR values should be used to determine the&#xD;
             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>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=B7921001&amp;StudyName=Study%20to%20Evaluate%20Safety%20and%20Tolerability%20of%20Single%20Ascending%20Doses%20of%20Multiple%20Formulations%20of%20PF-06650833%20in%20Healthy%20Subjects%20Under%20Fa</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>July 1, 2015</last_update_submitted>
  <last_update_submitted_qc>July 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 2, 2015</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/NCT02224651
org study id: B7921001
secondary id: IRAK4 FIH
nct id: NCT02224651
lead sponsor: 
has dmc: No
This single ascending dose study is the first evaluation of PF-06650833 in humans. The goals
      are to assess the safety, tolerability and blood levels of ascending doses of multiple
      formulations of PF-06650833 and to perform a preliminary assessment of the effect of food on
      exposure, in healthy subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events
time frame: Baseline-5 days
measure: Changes from baseline in vital signs ( blood pressure, pulse rate, respiratory rate and orthostatic blood pressure)
time frame: Baseline-5 days
measure: Changes from baseline in ECG parameters (standard 12 lead ECG and telemetry)
time frame: Baseline-5 days
description: Quantitative changes in ECG intervals
measure: Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology, chemistry (including, cardiac enzymes CK, CK MB and cardiac Troponin I), serum myoglobin, urinalysis
time frame: Baseline-5 days
measure: Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, Cmax(dn), AUCinf(dn), AUClast(dn), t½, mean residence time (MRT) for IR and MR formulations under fasted condition
time frame: Baseline-5 days
measure: Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, Cmax(dn), AUCinf(dn), AUClast(dn), t½, mean residence time (MRT) for IR and MR formulations under fed condition
time frame: Baseline-5 days
arm group label: (1-1000mg) Immediate Release formulation
arm group type: Experimental
arm group label: Immediate Release Placebo arm
arm group type: Placebo Comparator
arm group label: (10-500) mg Modified Release formulation
arm group type: Experimental
arm group label: Modified Release Placebo arm
arm group type: Placebo Comparator
intervention type: Drug
intervention name: PF-06650833
description: Subjects will receive sequential single escalating doses of 1-1000 mg of Immediate Release of PF-06650833 (as solution/suspension) under fed and / or fasted conditions.
arm group label: (1-1000mg) Immediate Release formulation
intervention type: Drug
intervention name: Placebo
description: Subjects will receive sequential single escalating doses of PF-06650833 matching placebo (as solution/suspension) under fed and/ or fasted conditions.
arm group label: Immediate Release Placebo arm
intervention type: Drug
intervention name: PF-06650833
description: Subjects will receive sequential single escalating doses of 10-500 mg of Modified Release of PF-06650833 (as capsule) under fed and / or fasted conditions.
arm group label: (10-500) mg Modified Release formulation
intervention type: Drug
intervention name: Placebo
description: Subjects will receive sequential single escalating doses of PF-06650833 matching placebo (as capsule) under fed and/ or fasted conditions.
arm group label: Modified Release Placebo arm
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=B7921001&StudyName=Study%20to%20Evaluate%20Safety%20and%20Tolerability%20of%20Single%20Ascending%20Doses%20of%20Multiple%20Formulations%20of%20PF-06650833%20in%20Healthy%20Subjects%20Under%20Fa
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor