<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/NCT01710020</url>
  </required_header>
  <id_info>
    <org_study_id>A3921004</org_study_id>
    <nct_id>NCT01710020</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease</brief_title>
  <official_title>Phase 1, Open-Label Study Of The Pharmacokinetics, Non-Renal Clearance And Dialyzability Of CP-690,550 In Subjects With End-Stage Renal Disease Undergoing Hemodialysis</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>
      There were 2 study periods in this study. In the Period 1, CP-690,550 was to be administered&#xD;
      approximately 1 to 2 hours following hemodialysis. If significant non-renal clearance of the&#xD;
      drug occurred such that dialyzability of CP-690,550 could not be assessed in Period 1, a&#xD;
      second period (Period 2) will be conducted. In Period 2, a single dose of drug will be&#xD;
      administered approximately 4 hours prior to hemodialysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2003</start_date>
  <completion_date type="Actual">June 2003</completion_date>
  <primary_completion_date type="Actual">June 2003</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group 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 - ∞)]</measure>
    <time_frame>0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hours (hrs) post-dose in Period 1</time_frame>
    <description>AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)</measure>
    <time_frame>0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1</time_frame>
    <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Decay Half-Life (t1/2)</measure>
    <time_frame>0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1</time_frame>
    <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral Clearance (CLpo)</measure>
    <time_frame>0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1</time_frame>
    <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing given dose of drug with AUC.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dialyser Clearance (CL HD) From 0 to 1 Hour</measure>
    <time_frame>0 to 1 hrs during hemodialysis started 4 hrs post-dose in Period 2</time_frame>
    <description>Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided (/) by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dialyser Clearance (CL HD) From 1 to 2 Hour</measure>
    <time_frame>1 to 2 hrs during hemodialysis started 4 hrs post-dose in Period 2</time_frame>
    <description>Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dialyser Clearance (CL HD) From 2 to 3 Hour</measure>
    <time_frame>2 to 3 hrs during hemodialysis started 4 hrs post-dose in Period 2</time_frame>
    <description>Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dialyser Clearance (CL HD) From 3 to 4 Hour</measure>
    <time_frame>3 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2</time_frame>
    <description>Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fraction of Unbound Drug (fu)</measure>
    <time_frame>2 hours post-dose in Period 1</time_frame>
    <description>Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Overall Dialyser Clearance (CL HD)</measure>
    <time_frame>0 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2</time_frame>
    <description>Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).</description>
  </other_outcome>
  <other_outcome>
    <measure>Dialyser Clearance (CL HD) From 3 to 3.5 Hour</measure>
    <time_frame>3 to 3.5 hrs during hemodialysis started 4 hrs post-dose in Period 2</time_frame>
    <description>Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>End-Stage Renal Disease</condition>
  <condition>Hemodialysis</condition>
  <arm_group>
    <arm_group_label>CP-690,550</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CP-690,550</intervention_name>
    <description>CP-690,550 10 mg oral powder for constitution</description>
    <arm_group_label>CP-690,550</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with end-stage renal disease&#xD;
&#xD;
          -  Subjects need hemodialysis 3 times weekly&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with evidence or history of clinically significant disease, excluding those&#xD;
             common for subjects with End-Stage Renal Disease (ESRD).&#xD;
&#xD;
          -  Subjects with any condition possibly affecting drug absorption.&#xD;
&#xD;
          -  Subjects with malignancies with the exception of adequately treated basal cell&#xD;
             carcinoma of the skin.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</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>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pfizer Investigational Site</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921004&amp;StudyName=Pharmacokinetics%20And%20Dialysability%20Of%20CP-690%2C550%20In%20Subjects%20With%20End-Stage%20Renal%20Disease</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <results_first_submitted>November 19, 2012</results_first_submitted>
  <results_first_submitted_qc>November 19, 2012</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 18, 2012</results_first_posted>
  <last_update_submitted>November 19, 2012</last_update_submitted>
  <last_update_submitted_qc>November 19, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CP-690</keyword>
  <keyword>550</keyword>
  <keyword>pharmacokinetics</keyword>
  <keyword>end-stage renal disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tofacitinib</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CP-690,550 (10 mg OPC)</title>
          <description>Single oral dose of CP-690,550 10 milligram (mg) oral powder for constitution (OPC) 1 to 2 hours (hrs) post-hemodialysis in Period 1 followed by single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2. A washout period of at least 14 days was maintained between each intervention period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Washout Period (at Least 14 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Entire Study Population</title>
          <description>Includes all participants enrolled in the study.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.9" spread="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]</title>
        <description>AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).</description>
        <time_frame>0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hours (hrs) post-dose in Period 1</time_frame>
        <population>Analysis set included all participants who received study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 (Period 1)</title>
            <description>Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]</title>
          <description>AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).</description>
          <population>Analysis set included all participants who received study medication.</population>
          <units>nanogram*hour/milliliter (ng*hr/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="396" spread="158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)</title>
        <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)</description>
        <time_frame>0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1</time_frame>
        <population>Analysis set included all participants who received study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 (Period 1)</title>
            <description>Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)</title>
          <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)</description>
          <population>Analysis set included all participants who received study medication.</population>
          <units>ng*hr/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="385" spread="151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Plasma Concentration (Cmax)</title>
        <time_frame>0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1</time_frame>
        <population>Analysis set included all participants who received study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 (Period 1)</title>
            <description>Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax)</title>
          <population>Analysis set included all participants who received study medication.</population>
          <units>nanogram/milliliter (ng/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106" spread="23.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to Reach Maximum Observed Plasma Concentration (Tmax)</title>
        <time_frame>0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1</time_frame>
        <population>Analysis set included all participants who received study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 (Period 1)</title>
            <description>Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum Observed Plasma Concentration (Tmax)</title>
          <population>Analysis set included all participants who received study medication.</population>
          <units>hr</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0.5" upper_limit="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Decay Half-Life (t1/2)</title>
        <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.</description>
        <time_frame>0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1</time_frame>
        <population>Analysis set included all participants who received study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 (Period 1)</title>
            <description>Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Decay Half-Life (t1/2)</title>
          <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.</description>
          <population>Analysis set included all participants who received study medication.</population>
          <units>hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.46" spread="1.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Oral Clearance (CLpo)</title>
        <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing given dose of drug with AUC.</description>
        <time_frame>0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1</time_frame>
        <population>Analysis set included all participants who received study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 (Period 1)</title>
            <description>Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Oral Clearance (CLpo)</title>
          <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing given dose of drug with AUC.</description>
          <population>Analysis set included all participants who received study medication.</population>
          <units>milliliter/minute (mL/min)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="501" spread="243"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Dialyser Clearance (CL HD) From 0 to 1 Hour</title>
        <description>Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided (/) by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).</description>
        <time_frame>0 to 1 hrs during hemodialysis started 4 hrs post-dose in Period 2</time_frame>
        <population>Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 (Period 2)</title>
            <description>Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Dialyser Clearance (CL HD) From 0 to 1 Hour</title>
          <description>Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided (/) by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).</description>
          <population>Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="311" spread="124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Dialyser Clearance (CL HD) From 1 to 2 Hour</title>
        <description>Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).</description>
        <time_frame>1 to 2 hrs during hemodialysis started 4 hrs post-dose in Period 2</time_frame>
        <population>Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 (Period 2)</title>
            <description>Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Dialyser Clearance (CL HD) From 1 to 2 Hour</title>
          <description>Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).</description>
          <population>Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="325" spread="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Dialyser Clearance (CL HD) From 2 to 3 Hour</title>
        <description>Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).</description>
        <time_frame>2 to 3 hrs during hemodialysis started 4 hrs post-dose in Period 2</time_frame>
        <population>Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 (Period 2)</title>
            <description>Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Dialyser Clearance (CL HD) From 2 to 3 Hour</title>
          <description>Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).</description>
          <population>Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="332" spread="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Dialyser Clearance (CL HD) From 3 to 4 Hour</title>
        <description>Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).</description>
        <time_frame>3 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2</time_frame>
        <population>Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 (Period 2)</title>
            <description>Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Dialyser Clearance (CL HD) From 3 to 4 Hour</title>
          <description>Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).</description>
          <population>Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="292" spread="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fraction of Unbound Drug (fu)</title>
        <description>Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration.</description>
        <time_frame>2 hours post-dose in Period 1</time_frame>
        <population>Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 (Period 1)</title>
            <description>Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Fraction of Unbound Drug (fu)</title>
          <description>Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration.</description>
          <population>Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.390" spread="0.042"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Overall Dialyser Clearance (CL HD)</title>
        <description>Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).</description>
        <time_frame>0 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2</time_frame>
        <population>Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 (Period 2)</title>
            <description>Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Dialyser Clearance (CL HD)</title>
          <description>Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).</description>
          <population>Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="318" spread="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Dialyser Clearance (CL HD) From 3 to 3.5 Hour</title>
        <description>Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).</description>
        <time_frame>3 to 3.5 hrs during hemodialysis started 4 hrs post-dose in Period 2</time_frame>
        <population>Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 (Period 2)</title>
            <description>Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Dialyser Clearance (CL HD) From 3 to 3.5 Hour</title>
          <description>Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).</description>
          <population>Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="377" spread="200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>CP-690,550 (Period 1)</title>
          <description>Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.</description>
        </group>
        <group group_id="E2">
          <title>CP-690,550 (Period 2)</title>
          <description>Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>COSTART</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer, Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01710020
org study id: A3921004
nct id: NCT01710020
lead sponsor: 
has dmc: No
There were 2 study periods in this study. In the Period 1, CP-690,550 was to be administered
      approximately 1 to 2 hours following hemodialysis. If significant non-renal clearance of the
      drug occurred such that dialyzability of CP-690,550 could not be assessed in Period 1, a
      second period (Period 2) will be conducted. In Period 2, a single dose of drug will be
      administered approximately 4 hours prior to hemodialysis.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hours (hrs) post-dose in Period 1
description: AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1
description: Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1
measure: Plasma Decay Half-Life (t1/2)
time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1
description: Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
measure: Oral Clearance (CLpo)
time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1
description: Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing given dose of drug with AUC.
measure: Dialyser Clearance (CL HD) From 0 to 1 Hour
time frame: 0 to 1 hrs during hemodialysis started 4 hrs post-dose in Period 2
description: Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided (/) by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).
measure: Dialyser Clearance (CL HD) From 1 to 2 Hour
time frame: 1 to 2 hrs during hemodialysis started 4 hrs post-dose in Period 2
description: Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).
measure: Dialyser Clearance (CL HD) From 2 to 3 Hour
time frame: 2 to 3 hrs during hemodialysis started 4 hrs post-dose in Period 2
description: Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).
measure: Dialyser Clearance (CL HD) From 3 to 4 Hour
time frame: 3 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2
description: Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).
measure: Fraction of Unbound Drug (fu)
time frame: 2 hours post-dose in Period 1
description: Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration.
measure: Overall Dialyser Clearance (CL HD)
time frame: 0 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2
description: Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).
measure: Dialyser Clearance (CL HD) From 3 to 3.5 Hour
time frame: 3 to 3.5 hrs during hemodialysis started 4 hrs post-dose in Period 2
description: Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).
arm group label: CP-690,550
arm group type: Experimental
intervention type: Drug
intervention name: CP-690,550
description: CP-690,550 10 mg oral powder for constitution
arm group label: CP-690,550
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921004&StudyName=Pharmacokinetics%20And%20Dialysability%20Of%20CP-690%2C550%20In%20Subjects%20With%20End-Stage%20Renal%20Disease
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
mesh term: Tofacitinib
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 