<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/NCT03280173</url>
  </required_header>
  <id_info>
    <org_study_id>B3461054</org_study_id>
    <secondary_id>2017-002769-23</secondary_id>
    <nct_id>NCT03280173</nct_id>
  </id_info>
  <brief_title>A Study Comparing the Amounts of 2 Different Forms of Tafamidis (PF06291826), Both With and Without Food, In the Blood</brief_title>
  <official_title>A Phase 1, Open-label, Randomized, Four-period, Four-sequence, Single-dose, Crossover Study In Healthy Volunteers, To Determine The Relative Bioavailability Of Pf-06291826 61 Mga Tafamidis Free Acid Soft Gelatin Capsules Compared To Commercial 4 × 20 Mg Tafamidis Meglumine Soft Gelatin Capsules Administered Under Fasted And Fed Conditions And The Effect Of Food On The Oral Bioavailability Of Pf-06291826 61 Mga Tafamidis Free Acid Soft Gelatin Capsules</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 of tafamidis will be compared under both fed and fasted conditions.&#xD;
      Subjects will be fasted overnight or fed. After swallowing one of the tafamidis formulations,&#xD;
      tafamidis blood concentrations will be measured periodically for 8 days. After 16 days,&#xD;
      subjects will take a different formulation in the fed or fasted state or take the same&#xD;
      formulation in the opposite feeding condition. This will be repeated, 16 days apart, until&#xD;
      all subjects have taken each formulation both fed and fasted.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">February 23, 2018</completion_date>
  <primary_completion_date type="Actual">February 23, 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 0-72 hours (AUC72)</measure>
    <time_frame>72 hrs</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>maximum observed plasma concentration (Cmax)</measure>
    <time_frame>168 hrs</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)</measure>
    <time_frame>168 hrs</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time (MRT)</measure>
    <time_frame>168 hrs</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>168 hrs</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Decay Half-Life (t1/2)</measure>
    <time_frame>168 hrs</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve from zero to infinity (AUCinf)</measure>
    <time_frame>168 hrs</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>61 mgA tafamidis free acid soft gelatin capsule fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>fasted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>61 mgA tafamidis free acid soft gelatin capsule fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>fed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4 × 20 mg tafamidis meglumine soft gelatin capsules fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>fed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4 × 20 mg tafamidis meglumine soft gelatin capsules fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>fasted</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tafamidis</intervention_name>
    <description>bioavailability study</description>
    <arm_group_label>4 × 20 mg tafamidis meglumine soft gelatin capsules fasted</arm_group_label>
    <arm_group_label>4 × 20 mg tafamidis meglumine soft gelatin capsules fed</arm_group_label>
    <arm_group_label>61 mgA tafamidis free acid soft gelatin capsule fasted</arm_group_label>
    <arm_group_label>61 mgA tafamidis free acid soft gelatin capsule fed</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;
&#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=B3461054&amp;StudyName=A+Phase+1%2C+Open-label%2C+Randomized%2C+Four-period%2C+Four-sequence%2C+Single-dose%2C+Crossover+Study+In+Healthy+Volunteers%2C+To+Determine+The+Relative+Bioavailability+Of+Pf-06291826+61+Mga+Tafamidis+Free+Acid+Soft+Gelatin+Capsules+Compared+To+Commercial+4+%C3%97+20+Mg+Tafamidis+Meglumine+Soft+Gelatin+Capsules+Administered+Under+Fasted+And+Fed+Conditions+And+The+Effect+Of+Food+On+The+Oral+Bioavailability+Of+Pf-06291826+61+Mga+Tafamidis+Free+Acid+Soft+Gelatin+Capsules</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>April 5, 2018</last_update_submitted>
  <last_update_submitted_qc>April 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 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/NCT03280173
org study id: B3461054
secondary id: 2017-002769-23
nct id: NCT03280173
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
2 different formulations of tafamidis will be compared under both fed and fasted conditions.
      Subjects will be fasted overnight or fed. After swallowing one of the tafamidis formulations,
      tafamidis blood concentrations will be measured periodically for 8 days. After 16 days,
      subjects will take a different formulation in the fed or fasted state or take the same
      formulation in the opposite feeding condition. This will be repeated, 16 days apart, until
      all subjects have taken each formulation both fed and fasted.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Area under the concentration-time curve 0-72 hours (AUC72)
time frame: 72 hrs
measure: maximum observed plasma concentration (Cmax)
time frame: 168 hrs
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
time frame: 168 hrs
measure: Mean residence time (MRT)
time frame: 168 hrs
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
time frame: 168 hrs
measure: Plasma Decay Half-Life (t1/2)
time frame: 168 hrs
measure: Area under the curve from zero to infinity (AUCinf)
time frame: 168 hrs
arm group label: 61 mgA tafamidis free acid soft gelatin capsule fed
arm group type: Experimental
description: fasted
arm group label: 61 mgA tafamidis free acid soft gelatin capsule fasted
arm group type: Experimental
description: fed
arm group label: 4 × 20 mg tafamidis meglumine soft gelatin capsules fed
arm group type: Experimental
description: fed
arm group label: 4 × 20 mg tafamidis meglumine soft gelatin capsules fasted
arm group type: Experimental
description: fasted
intervention type: Drug
intervention name: tafamidis
description: bioavailability study
arm group label: 4 × 20 mg tafamidis meglumine soft gelatin capsules fasted
arm group label: 4 × 20 mg tafamidis meglumine soft gelatin capsules fed
arm group label: 61 mgA tafamidis free acid soft gelatin capsule fasted
arm group label: 61 mgA tafamidis free acid soft gelatin capsule fed
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=B3461054&StudyName=A+Phase+1%2C+Open-label%2C+Randomized%2C+Four-period%2C+Four-sequence%2C+Single-dose%2C+Crossover+Study+In+Healthy+Volunteers%2C+To+Determine+The+Relative+Bioavailability+Of+Pf-06291826+61+Mga+Tafamidis+Free+Acid+Soft+Gelatin+Capsules+Compared+To+Commercial+4+%C3%97+20+Mg+Tafamidis+Meglumine+Soft+Gelatin+Capsules+Administered+Under+Fasted+And+Fed+Conditions+And+The+Effect+Of+Food+On+The+Oral+Bioavailability+Of+Pf-06291826+61+Mga+Tafamidis+Free+Acid+Soft+Gelatin+Capsules
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