<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/NCT03266705</url>
  </required_header>
  <id_info>
    <org_study_id>B3461056</org_study_id>
    <secondary_id>2017-002572-15</secondary_id>
    <nct_id>NCT03266705</nct_id>
  </id_info>
  <brief_title>A Study Comparing Amounts of 2 Different Forms of Tafamidis (PF-6291826) in the Blood</brief_title>
  <official_title>A Phase 1, Open-label, Randomized, Crossover, Multiple Dose, Pivotal Bioequivalence Study To Compare Pf-06291826 4 X 20 Mg Tafamidis Meglumine And 61 Mga Tafamidis Free Acid Soft Gelatin Capsules Administered Under Fasted Conditions To Healthy Volunteers</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>
      2 different formulations and doses of tafamidis will be compared. All subjects will receive&#xD;
      both doses/formulations. Subjects will take tafamidis for 7 days, on the first 2 days they&#xD;
      will take tafamidis twice, 12 hours apart and then once a day for the next 5 days. Subjects&#xD;
      will be fasted before taking the drug. Blood samples will be taken to measure the amount of&#xD;
      tafamidis starting on day 7 and ending on day 8. At least 16 days after the first&#xD;
      formulation/dose is given, all subjects will repeat the procedure with the other&#xD;
      formulation/dose.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Actual">March 1, 2018</completion_date>
  <primary_completion_date type="Actual">February 15, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the concentration-time curve (AUC)</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>maximum observed plasma concentration (Cmax)</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>minimum observed plasma concentration (Cmin)</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum observed plasma concentration (Tmax)</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>61 mgA tafamidis free acid soft gelatin capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>4x20 mg tafamidis meglumine soft gelatin capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tafamidis</intervention_name>
    <description>bioequivalence study</description>
    <arm_group_label>4x20 mg tafamidis meglumine soft gelatin capsule</arm_group_label>
    <arm_group_label>61 mgA tafamidis free acid soft gelatin capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males of females of non-childbearing potential&#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;
          -  Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg&#xD;
             (diastolic).&#xD;
&#xD;
          -  Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days&#xD;
             of the study.&#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;
          -  Pregnant female subjects; breastfeeding female subjects; male subjects with partners&#xD;
             currently pregnant; male subjects able to father children who are unwilling or unable&#xD;
             to use a highly effective method of contraception.&#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=B3461056&amp;StudyName=A+Phase+1%2C+Open-label%2C+Randomized%2C+Crossover%2C+Multiple+Dose%2C+Pivotal+Bioequivalence+Study+To+Compare+Pf-06291826+4+X+20+Mg+Tafamidis+Meglumine+And+61+Mga+Tafamidis+Free+Acid+Soft+Gelatin+Capsules+Administered+Under+Fasted+Conditions+To+Healthy+Volunteers</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>May 11, 2018</last_update_submitted>
  <last_update_submitted_qc>May 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/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/NCT03266705
org study id: B3461056
secondary id: 2017-002572-15
nct id: NCT03266705
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
2 different formulations and doses of tafamidis will be compared. All subjects will receive
      both doses/formulations. Subjects will take tafamidis for 7 days, on the first 2 days they
      will take tafamidis twice, 12 hours apart and then once a day for the next 5 days. Subjects
      will be fasted before taking the drug. Blood samples will be taken to measure the amount of
      tafamidis starting on day 7 and ending on day 8. At least 16 days after the first
      formulation/dose is given, all subjects will repeat the procedure with the other
      formulation/dose.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Area under the concentration-time curve (AUC)
time frame: 24 hours
measure: maximum observed plasma concentration (Cmax)
time frame: 24 hours
measure: minimum observed plasma concentration (Cmin)
time frame: 24 hours
measure: Time to maximum observed plasma concentration (Tmax)
time frame: 24 hours
arm group label: 61 mgA tafamidis free acid soft gelatin capsule
arm group type: Experimental
arm group label: 4x20 mg tafamidis meglumine soft gelatin capsule
arm group type: Experimental
intervention type: Drug
intervention name: tafamidis
description: bioequivalence study
arm group label: 4x20 mg tafamidis meglumine soft gelatin capsule
arm group label: 61 mgA tafamidis free acid soft gelatin capsule
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=B3461056&StudyName=A+Phase+1%2C+Open-label%2C+Randomized%2C+Crossover%2C+Multiple+Dose%2C+Pivotal+Bioequivalence+Study+To+Compare+Pf-06291826+4+X+20+Mg+Tafamidis+Meglumine+And+61+Mga+Tafamidis+Free+Acid+Soft+Gelatin+Capsules+Administered+Under+Fasted+Conditions+To+Healthy+Volunteers
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
sharing ipd: No
ipd description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests