<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/NCT02189330</url>
  </required_header>
  <id_info>
    <org_study_id>B3461030</org_study_id>
    <nct_id>NCT02189330</nct_id>
  </id_info>
  <brief_title>A Study To Estimate How Much Tafamidis Created In Different Ways Can Be Measured in Blood Samples</brief_title>
  <official_title>A Phase 1, Open-Label, Randomized, 2-Cohort, Crossover, Single Dose Study to Estimate the Relative Bioavailability of PF 06291826 (Tafamidis) Following Administration of Two Oral Formulations Versus Commercial Capsule in Healthy Subjects Under Fasted 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>
      All subjects in this study will be given tafamidis. After swallowing a single pill of&#xD;
      tafamidis, measurements including blood samples will be compared to see if tafamidis made in&#xD;
      different ways is about the same. After approximately 28 days subjects will be given another&#xD;
      pill of tafamidis and the study measurements will be repeated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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 Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]</measure>
    <time_frame>168 hours</time_frame>
    <description>AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>168 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)</measure>
    <time_frame>168 hours</time_frame>
    <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>6</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Tafamidis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Tafamudus Free Acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>20 mg new soft gelatin capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>4 capsules of 20 mg tafamidis of commercial formulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>4 capsules of 12.2 mg tafamidis of free acid tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tafamidis</intervention_name>
    <description>20 mg of current commercial formulation.</description>
    <arm_group_label>Tafamidis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tafamidis</intervention_name>
    <description>12.2 mgA free acid tablet.</description>
    <arm_group_label>Tafamudus Free Acid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tafamidis</intervention_name>
    <description>20 mg new soft gelatin capsule.</description>
    <arm_group_label>20 mg new soft gelatin capsule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tafamidis</intervention_name>
    <description>4 capsules of 20 mg tafamidis of current commercial formulation.</description>
    <arm_group_label>4 capsules of 20 mg tafamidis of commercial formulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tafamidis</intervention_name>
    <description>4 capsules of 12.2 mg tafamidis of free acid tablet..</description>
    <arm_group_label>4 capsules of 12.2 mg tafamidis of free acid tablet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males or females of non-child bearing potential.&#xD;
&#xD;
          -  Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).&#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;
      </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 Investigational Site</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=B3461030&amp;StudyName=A%20Study%20To%20Estimate%20How%20Much%20Tafamidis%20Created%20In%20Different%20Ways%20Can%20Be%20Measured%20in%20Blood%20Samples</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>May 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>July 14, 2014</last_update_submitted>
  <last_update_submitted_qc>July 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2014</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/NCT02189330
org study id: B3461030
nct id: NCT02189330
lead sponsor: 
has dmc: No
All subjects in this study will be given tafamidis. After swallowing a single pill of
      tafamidis, measurements including blood samples will be compared to see if tafamidis made in
      different ways is about the same. After approximately 28 days subjects will be given another
      pill of tafamidis and the study measurements will be repeated.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
time frame: 168 hours
description: AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: 168 hours
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
time frame: 168 hours
description: Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
time frame: 6
arm group label: Tafamidis
arm group type: Experimental
arm group label: Tafamudus Free Acid
arm group type: Experimental
arm group label: 20 mg new soft gelatin capsule
arm group type: Experimental
arm group label: 4 capsules of 20 mg tafamidis of commercial formulation
arm group type: Experimental
arm group label: 4 capsules of 12.2 mg tafamidis of free acid tablet
arm group type: Experimental
intervention type: Drug
intervention name: Tafamidis
description: 20 mg of current commercial formulation.
arm group label: Tafamidis
intervention type: Drug
intervention name: Tafamidis
description: 12.2 mgA free acid tablet.
arm group label: Tafamudus Free Acid
intervention type: Drug
intervention name: Tafamidis
description: 20 mg new soft gelatin capsule.
arm group label: 20 mg new soft gelatin capsule
intervention type: Drug
intervention name: Tafamidis
description: 4 capsules of 20 mg tafamidis of current commercial formulation.
arm group label: 4 capsules of 20 mg tafamidis of commercial formulation
intervention type: Drug
intervention name: Tafamidis
description: 4 capsules of 12.2 mg tafamidis of free acid tablet..
arm group label: 4 capsules of 12.2 mg tafamidis of free acid tablet
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=B3461030&StudyName=A%20Study%20To%20Estimate%20How%20Much%20Tafamidis%20Created%20In%20Different%20Ways%20Can%20Be%20Measured%20in%20Blood%20Samples
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor