<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/NCT01731327</url>
  </required_header>
  <id_info>
    <org_study_id>A3921132</org_study_id>
    <nct_id>NCT01731327</nct_id>
  </id_info>
  <brief_title>A Phase 1 Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of A Modified-Release (MR) Formulation Of Tofacitinib In Healthy Volunteers</brief_title>
  <official_title>A Phase 1, Randomized, Open-Label, 2-Way Crossover Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of Tofacitinib Following Single Oral Dose Of MR 11 mg Compared To MR 22 mg In 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will explore the drug behavior and safety following single doses of tofacitinib&#xD;
      modified-release (MR) 11 mg and MR 22 mg in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>AUCinf(dn): Area Under the Curve From Time Zero to Infinity, dose-normalized</measure>
    <time_frame>72 hours post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax(dn): Maximum Observed Plasma Concentration (Cmax), dose normalized</measure>
    <time_frame>72 hours post dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUClast(dn): Area Under the Curve From Time Zero to Last Quantifiable Concentration, dose normalized</measure>
    <time_frame>72 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCinf: Area Under the Curve From Time Zero to Infinity</measure>
    <time_frame>72 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax: Maximum Observed Plasma Concentration</measure>
    <time_frame>72 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUClast: Area Under the Curve From Time Zero to Last Quantifiable Concentration</measure>
    <time_frame>72 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax: Amount of time drug takes to reach Cmax</measure>
    <time_frame>72 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t ½: Terminal elimination half-life</measure>
    <time_frame>72 hours post dose</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Experimental Treatment A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Treatment B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tofacitinib modified-release (MR) formulation</intervention_name>
    <description>A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.</description>
    <arm_group_label>Experimental Treatment A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tofacitinib modified-release (MR) formulation</intervention_name>
    <description>A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.</description>
    <arm_group_label>Experimental Treatment B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subjects and/or healthy female subjects who are of non-childbearing&#xD;
             potential.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or&#xD;
             allergic disease;&#xD;
&#xD;
          -  Clinically significant infections within the past 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 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>Singapore</city>
        <zip>188770</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921132&amp;StudyName=A%20Phase%201%20Study%20To%20Evaluate%20The%20Pharmacokinetics%20%28PK%29%2C%20Safety%2C%20And%20Bioavailability%20Of%20A%20Modified-Release%20%28MR%29%20Formulation%20Of%20T</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>December 20, 2012</last_update_submitted>
  <last_update_submitted_qc>December 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 24, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Phase 1</keyword>
  <keyword>relative bioavailability</keyword>
  <keyword>modified release</keyword>
  <keyword>tofacitinib</keyword>
  <keyword>CP-690</keyword>
  <keyword>550</keyword>
  <keyword>pharmacokinetic</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tofacitinib</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01731327
org study id: A3921132
nct id: NCT01731327
lead sponsor: 
has dmc: No
This study will explore the drug behavior and safety following single doses of tofacitinib
      modified-release (MR) 11 mg and MR 22 mg in healthy volunteers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: AUCinf(dn): Area Under the Curve From Time Zero to Infinity, dose-normalized
time frame: 72 hours post dose
measure: Cmax(dn): Maximum Observed Plasma Concentration (Cmax), dose normalized
time frame: 72 hours post dose
measure: AUClast(dn): Area Under the Curve From Time Zero to Last Quantifiable Concentration, dose normalized
time frame: 72 hours post dose
measure: AUCinf: Area Under the Curve From Time Zero to Infinity
time frame: 72 hours post dose
measure: Cmax: Maximum Observed Plasma Concentration
time frame: 72 hours post dose
measure: AUClast: Area Under the Curve From Time Zero to Last Quantifiable Concentration
time frame: 72 hours post dose
measure: Tmax: Amount of time drug takes to reach Cmax
time frame: 72 hours post dose
measure: t ½: Terminal elimination half-life
time frame: 72 hours post dose
arm group label: Experimental Treatment A
arm group type: Experimental
description: A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.
arm group label: Experimental Treatment B
arm group type: Experimental
description: A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.
intervention type: Drug
intervention name: tofacitinib modified-release (MR) formulation
description: A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.
arm group label: Experimental Treatment A
intervention type: Drug
intervention name: tofacitinib modified-release (MR) formulation
description: A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.
arm group label: Experimental Treatment B
criteria: 
gender: All
minimum age: 21 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
country: Singapore
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921132&StudyName=A%20Phase%201%20Study%20To%20Evaluate%20The%20Pharmacokinetics%20%28PK%29%2C%20Safety%2C%20And%20Bioavailability%20Of%20A%20Modified-Release%20%28MR%29%20Formulation%20Of%20T
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Tofacitinib