<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/NCT03308110</url>
  </required_header>
  <id_info>
    <org_study_id>B7921011</org_study_id>
    <secondary_id>2017-002052-88</secondary_id>
    <nct_id>NCT03308110</nct_id>
  </id_info>
  <brief_title>Bioavailability and Food Effect Study of Two Formulations of PF-06650833</brief_title>
  <official_title>A PHASE 1, SINGLE DOSE, OPEN LABEL, RANDOMIZED, 5-PERIOD CROSSOVER STUDY TO EVALUATE THE RELATIVE BIOAVAILABILITY AND FOOD EFFECT ON NEW MODIFIED RELEASE TABLET OF PF-06650833 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bioavailability and food effect of 2 formulations of PF-06650833 in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 8, 2017</start_date>
  <completion_date type="Actual">January 11, 2018</completion_date>
  <primary_completion_date type="Actual">December 8, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>0-96 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUClast</measure>
    <time_frame>0-96 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax under high fat meal fed conditions</measure>
    <time_frame>0-96 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters of PF-06650833 from plasma concentration (if data permits)</measure>
    <time_frame>0-96 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUClast under high fat meal fed conditions</measure>
    <time_frame>0-96 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Relative Bioavailability Cohort</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Relative Bioavailability cohort</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06650833</intervention_name>
    <description>Two formulations of PF-006650833</description>
    <arm_group_label>Relative Bioavailability Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy female subjects of nonchild bearing potential and/or male subjects who, at the&#xD;
             time of screening, are between the ages of 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 lb).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with any of the following characteristics/conditions will not be included in&#xD;
             the study:&#xD;
&#xD;
        Evidence or history of clinically significant hematological, renal, endocrine, pulmonary,&#xD;
        gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease&#xD;
        (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the&#xD;
        time of dosing).&#xD;
&#xD;
        Any condition possibly affecting drug absorption (eg, gastrectomy).&#xD;
&#xD;
          -  A positive urine drug test.&#xD;
&#xD;
          -  History of regular alcohol consumption within 6 months before screening.&#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 investigational product&#xD;
             (whichever is longer).&#xD;
&#xD;
          -  Screening supine BP greater than equal to 140 mm Hg (systolic) or more than equal to&#xD;
             90 mm Hg (diastolic), following at least 5 minutes of supine rest.&#xD;
&#xD;
          -  Pregnant female subjects; breastfeeding female subjects; female subjects of&#xD;
             childbearing potential;&#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 investigational product.&#xD;
&#xD;
          -  History of tuberculosis or active or latent or inadequately treated infection,&#xD;
             positive QuantiFERON-TB Gold test.&#xD;
&#xD;
        History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive&#xD;
        testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody&#xD;
        (HepBcAb), or hepatitis C antibody (HCVAb).&#xD;
&#xD;
        -Other acute or chronic medical or psychiatric condition including recent (within the past&#xD;
        year) or active suicidal ideation or behavior or laboratory abnormality&#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 Clinical Research Unit</name>
      <address>
        <city>Brussels</city>
        <zip>B-1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7921011&amp;StudyName=A+Phase+1%2C+Single+Dose%2C+Open+Label%2C+Randomized%2C+5-period+Crossover+Study+To+Evaluate+The+Relative+Bioavailability+And+Food+Effect+On+New+Modified+Release+Tablet+Of+Pf-06650833+In+Healthy+Subjects</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>April 17, 2019</last_update_submitted>
  <last_update_submitted_qc>April 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </patient_data>
  <!-- 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/NCT03308110
org study id: B7921011
secondary id: 2017-002052-88
nct id: NCT03308110
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Bioavailability and food effect of 2 formulations of PF-06650833 in healthy volunteers.
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Cmax
time frame: 0-96 hours
measure: AUClast
time frame: 0-96 hours
measure: Cmax under high fat meal fed conditions
time frame: 0-96 hours
measure: Pharmacokinetic parameters of PF-06650833 from plasma concentration (if data permits)
time frame: 0-96 hours
measure: AUClast under high fat meal fed conditions
time frame: 0-96 hours
arm group label: Relative Bioavailability Cohort
arm group type: Other
description: Relative Bioavailability cohort
intervention type: Drug
intervention name: PF-06650833
description: Two formulations of PF-006650833
arm group label: Relative Bioavailability Cohort
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: Belgium
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7921011&StudyName=A+Phase+1%2C+Single+Dose%2C+Open+Label%2C+Randomized%2C+5-period+Crossover+Study+To+Evaluate+The+Relative+Bioavailability+And+Food+Effect+On+New+Modified+Release+Tablet+Of+Pf-06650833+In+Healthy+Subjects
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.