<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/NCT04403776</url>
  </required_header>
  <id_info>
    <org_study_id>A3921213</org_study_id>
    <nct_id>NCT04403776</nct_id>
  </id_info>
  <brief_title>PK and Bioavailability Comparison of Tofacitinib Between a Modified Release and The Immediate Release Formulation</brief_title>
  <official_title>A Phase 1, Randomized, Open-Label, 2-Way Crossover Study To Evaluate Single Dose And Steady State PK And Bioavailability Between A Modified Release Tofacitinib (11 Mg QD) And The Immediate Release Tofacitinib (5 Mg BID) In Chinese 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>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study to characterize the single-dose and steady-state pharmacokinetics of tofacitinib&#xD;
      Modified Release (MR) formulation as well as to compare the extent of absorption of the MR 11&#xD;
      mg formulation (once daily) to that of the Immediate Release (IR) 5 mg formulation (twice&#xD;
      daily) of tofacitinib in Chinese healthy subjects under fasted conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Actual">February 12, 2019</completion_date>
  <primary_completion_date type="Actual">February 12, 2019</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>
    <intervention_model_description>Subjects will be randomized to one of the two treatment sequences. Each treatment sequence will consist of two periods, separated by a washout phase of no less than 72 hours from the AM dose on Day 7.&#xD;
Treatment A (Test): Single oral dose of tofacitinib MR 11 mg, administered as 1 x MR 11 mg tablet, in a fasting state on Day 1 followed by once daily dosing (QD) on Days 3, 4, 5, 6 and 7.&#xD;
Treatment B (Reference): Two separate oral doses (12 hours apart) of tofacitinib IR 5 mg, administered one in the morning in a fasting state and one in the evening at least 2 hours after dinner on Day 1 followed by 5 mg IR every 12 hours on Days 3, 4, 5, 6 and 7.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma concentration time profile from time zero extrapolated to infinite time (AUCinf)</measure>
    <time_frame>Plasma PK samples will be collected pre dose and after the Day 1 AM dose of MR and IR treatments and the PM dose of the IR treatment.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (AUClast)</measure>
    <time_frame>Plasma PK samples will be collected pre dose and after the Day 1 AM dose of MR and IR treatments and the PM dose of the IR treatment.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the concentration time profile for the 24 hour period (AUC24)</measure>
    <time_frame>Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Single-dose PK: maximum observed concentration (Cmax)</measure>
    <time_frame>Plasma PK samples will be collected pre dose and after the Day 1 AM dose of MR and IR treatments and the PM dose of the IR treatment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single-dose PK: time for Cmax (Tmax)</measure>
    <time_frame>Plasma PK samples will be collected pre dose and after the Day 1 AM dose of MR and IR treatments and the PM dose of the IR treatment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single-dose PK: terminal half-life (t1/2)</measure>
    <time_frame>Plasma PK samples will be collected pre dose and after the Day 1 AM dose of MR and IR treatments and the PM dose of the IR treatment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single-dose PK: area under the plasma concentration-time profile from time 0 to tau (AUCtau)</measure>
    <time_frame>Plasma PK samples will be collected pre dose and after the Day 1 AM dose of MR and IR treatments and the PM dose of the IR treatment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steady-state PK: Cmax</measure>
    <time_frame>Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steady-state PK: lowest concentration observed (Cmin)</measure>
    <time_frame>Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steady-state PK: average concentration (Cav)</measure>
    <time_frame>Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steady-state PK: Tmax</measure>
    <time_frame>Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steady-state PK: concentration at 24 hours (C24)</measure>
    <time_frame>Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steady-state PK: peak to trough ratio (PTR)</measure>
    <time_frame>Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steady-state PK: peak to trough fluctuation (PTF)</measure>
    <time_frame>Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steady-state PK: peak to trough swing (PTS)</measure>
    <time_frame>Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steady-state PK: observed accumulation ratio for AUC (Rac)</measure>
    <time_frame>Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steady-state PK: observed accumulation ratio for Cmax (Rac,Cmax)</measure>
    <time_frame>Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number (%) of subjects with treatment-emergent adverse events</measure>
    <time_frame>approximately 18 days</time_frame>
    <description>ECG, Clinical Laboratories, Vitals Signs and Physical Exams will be used as a safety measure to detect any AEs.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Treatment A, separated washout phase, followed Treatment B.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment A:&#xD;
Single oral dose of tofacitinib MR 11mg, administered as 1xMR 11mg tablet, in a fasting state on Day 1 followed by once daily dosing (QD) on Days 3, 4, 5, 6 and 7.&#xD;
washout phase: no later than 72 hours&#xD;
Treatment B:&#xD;
Two separate oral doses (12 hours apart) of tofacitinib IR 5mg, administered one in the morning in a fasting state and one in the evening at least 2 hours after dinner on Day 1 followed by 5 mg IR every 12 hours on Days 3, 4, 5, 6 and 7.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B, separated washout phase, followed Treatment A.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment A:&#xD;
Single oral dose of tofacitinib MR 11mg, administered as 1xMR 11mg tablet, in a fasting state on Day 1 followed by once daily dosing (QD) on Days 3, 4, 5, 6 and 7.&#xD;
Washout phase: no later than 72 hours&#xD;
Treatment B:&#xD;
Two separate oral doses (12 hours apart) of tofacitinib IR 5mg, administered one in the morning in a fasting state and one in the evening at least 2 hours after dinner on Day 1 followed by 5 mg IR every 12 hours on Days 3, 4, 5, 6 and 7.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tofacitinib MR 11 mg</intervention_name>
    <description>Single oral dose of tofacitinib MR 11 mg, administered as 1 x MR 11 mg tablet, in a fasting state on Day 1 followed by once daily dosing (QD) on Days 3, 4, 5, 6 and 7.</description>
    <arm_group_label>Treatment A, separated washout phase, followed Treatment B.</arm_group_label>
    <arm_group_label>Treatment B, separated washout phase, followed Treatment A.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tofacitinib IR 5 mg</intervention_name>
    <description>Two separate oral doses (12 hours apart) of tofacitinib IR 5 mg, administered one in the morning in a fasting state and one in the evening at least 2 hours after dinner on Day 1 followed by 5 mg IR every 12 hours on Days 3, 4, 5, 6 and 7.</description>
    <arm_group_label>Treatment A, separated washout phase, followed Treatment B.</arm_group_label>
    <arm_group_label>Treatment B, separated washout phase, followed Treatment A.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must be of Chinese ethnicity (individuals currently residing in mainland&#xD;
             China who were born in China and have both parents of Chinese descent).&#xD;
&#xD;
          -  Healthy male and/or female subjects of non-childbearing potential&#xD;
&#xD;
          -  Female subjects of non-childbearing potential must meet at least one of the following&#xD;
             criteria:&#xD;
&#xD;
          -  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;
             postmenopausal state;&#xD;
&#xD;
          -  Have undergone a documented hysterectomy and/or bilateral oophorectomy;&#xD;
&#xD;
          -  Have medically confirmed ovarian failure.&#xD;
&#xD;
          -  Body Mass Index (BMI) of 19.0 to 26.0 kg/m2; and a total body weight &gt;50 kg (110 lbs).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects presenting with any of the following will not be included in the study:&#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;
          -  Clinically significant infections within the past 3 months prior to first dosing (eg,&#xD;
             those requiring hospitalization or parenteral antibiotics, or as judged by the&#xD;
             Investigator), evidence of any infection within the past 7 days prior to first dosing,&#xD;
             history of disseminated herpes simplex infection or recurrent (&gt;1 episode) or&#xD;
             disseminated herpes zoster.&#xD;
&#xD;
          -  Any condition possibly affecting drug absorption (eg, gastrectomy, colon resection,&#xD;
             etc.).&#xD;
&#xD;
          -  Use of CYP3A4 inhibitors (eg, ketoconazole, ciprofloxacin, diltiazem) or inducers (eg,&#xD;
             phenytoin, carbamazepine, rifampin) within 14 days or 5 half lives (whichever is&#xD;
             longer) prior to dosing.&#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>Shuguang Hospital Affiliated to Shanghai University of TCM/Phase I Unit</name>
      <address>
        <city>Shanghai</city>
        <zip>201203</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=A3921213</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 4, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</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>Tofacitinib</mesh_term>
  </intervention_browse>
  <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/NCT04403776
org study id: A3921213
nct id: NCT04403776
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
A study to characterize the single-dose and steady-state pharmacokinetics of tofacitinib
      Modified Release (MR) formulation as well as to compare the extent of absorption of the MR 11
      mg formulation (once daily) to that of the Immediate Release (IR) 5 mg formulation (twice
      daily) of tofacitinib in Chinese healthy subjects under fasted conditions.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Subjects will be randomized to one of the two treatment sequences. Each treatment sequence will consist of two periods, separated by a washout phase of no less than 72 hours from the AM dose on Day 7.
Treatment A (Test): Single oral dose of tofacitinib MR 11 mg, administered as 1 x MR 11 mg tablet, in a fasting state on Day 1 followed by once daily dosing (QD) on Days 3, 4, 5, 6 and 7.
Treatment B (Reference): Two separate oral doses (12 hours apart) of tofacitinib IR 5 mg, administered one in the morning in a fasting state and one in the evening at least 2 hours after dinner on Day 1 followed by 5 mg IR every 12 hours on Days 3, 4, 5, 6 and 7.
primary purpose: Other
masking: None (Open Label)
measure: Area under the plasma concentration time profile from time zero extrapolated to infinite time (AUCinf)
time frame: Plasma PK samples will be collected pre dose and after the Day 1 AM dose of MR and IR treatments and the PM dose of the IR treatment.
measure: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (AUClast)
time frame: Plasma PK samples will be collected pre dose and after the Day 1 AM dose of MR and IR treatments and the PM dose of the IR treatment.
measure: Area under the concentration time profile for the 24 hour period (AUC24)
time frame: Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)
measure: Single-dose PK: maximum observed concentration (Cmax)
time frame: Plasma PK samples will be collected pre dose and after the Day 1 AM dose of MR and IR treatments and the PM dose of the IR treatment.
measure: Single-dose PK: time for Cmax (Tmax)
time frame: Plasma PK samples will be collected pre dose and after the Day 1 AM dose of MR and IR treatments and the PM dose of the IR treatment.
measure: Single-dose PK: terminal half-life (t1/2)
time frame: Plasma PK samples will be collected pre dose and after the Day 1 AM dose of MR and IR treatments and the PM dose of the IR treatment.
measure: Single-dose PK: area under the plasma concentration-time profile from time 0 to tau (AUCtau)
time frame: Plasma PK samples will be collected pre dose and after the Day 1 AM dose of MR and IR treatments and the PM dose of the IR treatment.
measure: Steady-state PK: Cmax
time frame: Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)
measure: Steady-state PK: lowest concentration observed (Cmin)
time frame: Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)
measure: Steady-state PK: average concentration (Cav)
time frame: Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)
measure: Steady-state PK: Tmax
time frame: Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)
measure: Steady-state PK: concentration at 24 hours (C24)
time frame: Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)
measure: Steady-state PK: peak to trough ratio (PTR)
time frame: Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)
measure: Steady-state PK: peak to trough fluctuation (PTF)
time frame: Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)
measure: Steady-state PK: peak to trough swing (PTS)
time frame: Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)
measure: Steady-state PK: observed accumulation ratio for AUC (Rac)
time frame: Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)
measure: Steady-state PK: observed accumulation ratio for Cmax (Rac,Cmax)
time frame: Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)
measure: Number (%) of subjects with treatment-emergent adverse events
time frame: approximately 18 days
description: ECG, Clinical Laboratories, Vitals Signs and Physical Exams will be used as a safety measure to detect any AEs.
arm group label: Treatment A, separated washout phase, followed Treatment B.
arm group type: Experimental
description: Treatment A:
Single oral dose of tofacitinib MR 11mg, administered as 1xMR 11mg tablet, in a fasting state on Day 1 followed by once daily dosing (QD) on Days 3, 4, 5, 6 and 7.
washout phase: no later than 72 hours
Treatment B:
Two separate oral doses (12 hours apart) of tofacitinib IR 5mg, administered one in the morning in a fasting state and one in the evening at least 2 hours after dinner on Day 1 followed by 5 mg IR every 12 hours on Days 3, 4, 5, 6 and 7.
arm group label: Treatment B, separated washout phase, followed Treatment A.
arm group type: Experimental
description: Treatment A:
Single oral dose of tofacitinib MR 11mg, administered as 1xMR 11mg tablet, in a fasting state on Day 1 followed by once daily dosing (QD) on Days 3, 4, 5, 6 and 7.
Washout phase: no later than 72 hours
Treatment B:
Two separate oral doses (12 hours apart) of tofacitinib IR 5mg, administered one in the morning in a fasting state and one in the evening at least 2 hours after dinner on Day 1 followed by 5 mg IR every 12 hours on Days 3, 4, 5, 6 and 7.
intervention type: Drug
intervention name: tofacitinib MR 11 mg
description: Single oral dose of tofacitinib MR 11 mg, administered as 1 x MR 11 mg tablet, in a fasting state on Day 1 followed by once daily dosing (QD) on Days 3, 4, 5, 6 and 7.
arm group label: Treatment A, separated washout phase, followed Treatment B.
arm group label: Treatment B, separated washout phase, followed Treatment A.
intervention type: Drug
intervention name: tofacitinib IR 5 mg
description: Two separate oral doses (12 hours apart) of tofacitinib IR 5 mg, administered one in the morning in a fasting state and one in the evening at least 2 hours after dinner on Day 1 followed by 5 mg IR every 12 hours on Days 3, 4, 5, 6 and 7.
arm group label: Treatment A, separated washout phase, followed Treatment B.
arm group label: Treatment B, separated washout phase, followed Treatment A.
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: China
url: https://pmiform.com/clinical-trial-info-request?StudyID=A3921213
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Tofacitinib
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.