<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/NCT02246673</url>
  </required_header>
  <id_info>
    <org_study_id>RDEA3170-204</org_study_id>
    <nct_id>NCT02246673</nct_id>
  </id_info>
  <brief_title>RDEA3170 and Febuxostat Combination Study in Gout Subjects</brief_title>
  <official_title>A Phase 2a, Randomized, Open-Label Study to Evaluate the Pharmacodynamic Effects and Safety of RDEA3170 Administered in Combination With Febuxostat Compared to Febuxostat Administered Alone in Adult Subjects With Gout</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ardea Biosciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ardea Biosciences, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic&#xD;
      (PD) effects and safety of RDEA3170 administered in combination with febuxostat compared to&#xD;
      febuxostat administered alone in adult subjects with gout.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum Urate Maximum Percentage (%) Change (Emax, CB)</measure>
    <time_frame>28 days</time_frame>
    <description>Maximum observed percentage (%) change from baseline in serum urate concentrations.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine Uric Acid % Change (0-24h) (Aeur, CB)</measure>
    <time_frame>28 days</time_frame>
    <description>Percentage (%) change from baseline in the amount of uric acid recovered in urine.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)</measure>
    <time_frame>28 days</time_frame>
    <description>Percentage (%) change from baseline in renal clearance of uric acid.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)</measure>
    <time_frame>28 days</time_frame>
    <description>Percentage (%) change from baseline in fractional excretion of uric acid.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>Days 7 to 28</time_frame>
    <description>Cmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Occurrence of Maximum Observed Concentration (Tmax)</measure>
    <time_frame>Days 7 to 28</time_frame>
    <description>Tmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)</measure>
    <time_frame>Days 7 to 28</time_frame>
    <description>AUC 0-24 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)</measure>
    <time_frame>Days 7 to 28</time_frame>
    <description>AUC last of multiple-dose RDEA3170 administered in combination with febuxostat from plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Terminal Half-life (t1/2)</measure>
    <time_frame>Days 7 to 28</time_frame>
    <description>t1/2 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Gout</condition>
  <arm_group>
    <arm_group_label>RDEA3170 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once daily (qd) with febuxostat 40mg (qd) for 7 days, and with febuxostat 80 mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RDEA3170 15 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RDEA3170 5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RDEA3170 2.5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RDEA3170 15 mg</intervention_name>
    <arm_group_label>RDEA3170 15 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RDEA3170 10 mg</intervention_name>
    <arm_group_label>RDEA3170 10 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RDEA3170 2.5</intervention_name>
    <arm_group_label>RDEA3170 2.5 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RDEA3170 5 mg</intervention_name>
    <arm_group_label>RDEA3170 15 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Febuxostat 40 mg</intervention_name>
    <arm_group_label>RDEA3170 10 mg</arm_group_label>
    <arm_group_label>RDEA3170 15 mg</arm_group_label>
    <arm_group_label>RDEA3170 2.5 mg</arm_group_label>
    <arm_group_label>RDEA3170 5 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Febuxostat 80 mg</intervention_name>
    <arm_group_label>RDEA3170 10 mg</arm_group_label>
    <arm_group_label>RDEA3170 15 mg</arm_group_label>
    <arm_group_label>RDEA3170 2.5 mg</arm_group_label>
    <arm_group_label>RDEA3170 5 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to understand the study procedures and the risks involved and is willing to&#xD;
             provide written informed consent before the first study-related activity.&#xD;
&#xD;
          -  Meets one or more criteria for the diagnosis of gout as per the American Rheumatism&#xD;
             Association Criteria for the Classification of Acute Arthritis of Primary Gout.&#xD;
&#xD;
          -  Body weight ≥ 50 kg (110 lbs) and a body mass index ≥ 18 and ≤ 45 kg/m2.&#xD;
&#xD;
          -  Screening serum urate level ≥ 8 mg/dL.&#xD;
&#xD;
          -  Free of any clinically significant disease or medical condition, per the&#xD;
             Investigator's judgment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to take colchicine for gout flare prophylaxis.&#xD;
&#xD;
          -  History or suspicion of kidney stones.&#xD;
&#xD;
          -  Any gastrointestinal disorder that affects motility and/or absorption.&#xD;
&#xD;
          -  Unstable angina, New York Heart Association class III or IV heart failure, ischemic&#xD;
             heart disease, stroke, or deep venous thrombosis within 12 months prior to Day 1; or&#xD;
             subject is currently receiving anticoagulants.&#xD;
&#xD;
          -  Screening laboratory parameters that are outside the normal limits and are considered&#xD;
             clinically significant by the Investigator.&#xD;
&#xD;
          -  Estimated creatinine clearance &lt; 60 mL/min calculated by the Cockcroft-Gault formula&#xD;
             using ideal body weight during the Screening period.&#xD;
&#xD;
          -  Taking losartan, fenofibrate, guaifenesin, or sodium-glucose linked transporter-2&#xD;
             inhibitors; chronic and stable doses are permitted if doses are stable for at least 14&#xD;
             days prior to study medication dosing.&#xD;
&#xD;
          -  Unable or unwilling to comply with the study requirements or has a situation or&#xD;
             condition that, in the opinion of the Investigator, may interfere with participation&#xD;
             in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>J. Hall</last_name>
    <role>Study Director</role>
    <affiliation>Ardea Biosciences, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <results_first_submitted>June 27, 2017</results_first_submitted>
  <results_first_submitted_qc>June 27, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 27, 2017</results_first_posted>
  <last_update_submitted>June 27, 2017</last_update_submitted>
  <last_update_submitted_qc>June 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gout</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Febuxostat</mesh_term>
    <mesh_term>Verinurad</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Sixty-four subjects were randomized and received at least 1 dose of randomized study medication. Five cohorts of approximately 12 adult subjects with gout per cohort were randomized into the study. Overall, a total of 60 subjects completed the study in accordance with the protocol.</recruitment_details>
      <pre_assignment_details>Cohorts 1 through 4 were conducted sequentially and Cohort 5 was conducted following review of the available PD/PK results of Cohort 2. Subjects in Cohorts 1 through 4 were randomized to 1 of 2 treatment sequences (ABCD or DCBA) in a 1:1 ration and subjects in Cohort 5 were randomized to 1 of 2 treatment sequences (EHGF or GFHE) in a 1:1 ratio.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1</title>
          <description>(RDEA3170 10 mg + Febuxostat 40 mg; RDEA3170 10 mg + Febuxostat 80 mg)</description>
        </group>
        <group group_id="P2">
          <title>Cohort 2</title>
          <description>(RDEA3170 15 mg + Febuxostat 40 mg; RDEA3170 15 mg + Febuxostat 80 mg)</description>
        </group>
        <group group_id="P3">
          <title>Cohort 3</title>
          <description>(RDEA3170 5 mg + Febuxostat 40 mg; RDEA3170 5 mg + Febuxostat 80 mg)</description>
        </group>
        <group group_id="P4">
          <title>Cohort 4</title>
          <description>(RDEA3170 2.5 mg + Febuxostat 40 mg; RDEA3170 2.5 mg + Febuxostat 80 mg)</description>
        </group>
        <group group_id="P5">
          <title>Cohort 5</title>
          <description>(RDEA3170 10 mg + Febuxostat 40 mg; RDEA3170 15 mg + Febuxostat 40 mg; RDEA3170 20 mg + Febuxostat 40 mg)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="14"/>
                <participants group_id="P5" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="12"/>
                <participants group_id="P5" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1</title>
        </group>
        <group group_id="B2">
          <title>Cohort 2</title>
        </group>
        <group group_id="B3">
          <title>Cohort 3</title>
        </group>
        <group group_id="B4">
          <title>Cohort 4</title>
        </group>
        <group group_id="B5">
          <title>Cohort 5</title>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="12"/>
            <count group_id="B4" value="14"/>
            <count group_id="B5" value="12"/>
            <count group_id="B6" value="64"/>
          </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" spread="8.9"/>
                    <measurement group_id="B2" value="50" spread="8.2"/>
                    <measurement group_id="B3" value="50" spread="8.5"/>
                    <measurement group_id="B4" value="48" spread="11.5"/>
                    <measurement group_id="B5" value="49" spread="10.9"/>
                    <measurement group_id="B6" value="48" spread="9.6"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="12"/>
                    <measurement group_id="B6" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Serum Urate Maximum Percentage (%) Change (Emax, CB)</title>
        <description>Maximum observed percentage (%) change from baseline in serum urate concentrations.</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Febuxostat 40 mg</title>
            <description>Days 7/14/21/28 Overall (Cohorts 1 through 5)</description>
          </group>
          <group group_id="O2">
            <title>Febuxostat 80 mg</title>
            <description>Days 7/28 Overall (Cohorts 1 through 5)</description>
          </group>
          <group group_id="O3">
            <title>RDEA3170 10 mg + Febuxostat 40 mg</title>
            <description>Days 7/14/21/28 Overall (Cohorts 1 and 5)</description>
          </group>
          <group group_id="O4">
            <title>RDEA3170 10 mg + Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohort 1)</description>
          </group>
          <group group_id="O5">
            <title>RDEA3170 15 mg + Febuxostat 40 mg</title>
            <description>Days 7/14/21/28 Overall (Cohorts 2 and 5)</description>
          </group>
          <group group_id="O6">
            <title>RDEA3170 15 mg + Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohort 2)</description>
          </group>
          <group group_id="O7">
            <title>RDEA3170 5 mg + Febuxostat 40 mg</title>
            <description>Days 14/21 Overall (Cohort 3)</description>
          </group>
          <group group_id="O8">
            <title>RDEA3170 5 mg + Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohort 3)</description>
          </group>
          <group group_id="O9">
            <title>RDEA3170 2.5 mg + Febuxostat 40 mg</title>
            <description>Days 14/21 Overall (Cohort 4)</description>
          </group>
          <group group_id="O10">
            <title>RDEA3170 2.5 mg + Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohort 4)</description>
          </group>
          <group group_id="O11">
            <title>RDEA3170 20 mg + Febuxostat 40 mg</title>
            <description>Days 14/21 Overall (Cohort 5)</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Urate Maximum Percentage (%) Change (Emax, CB)</title>
          <description>Maximum observed percentage (%) change from baseline in serum urate concentrations.</description>
          <units>Percentage (%)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="47"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="23"/>
                <count group_id="O6" value="11"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="12"/>
                <count group_id="O9" value="12"/>
                <count group_id="O10" value="12"/>
                <count group_id="O11" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-43.5" spread="1.10"/>
                    <measurement group_id="O2" value="-55.6" spread="1.37"/>
                    <measurement group_id="O3" value="-70.4" spread="1.35"/>
                    <measurement group_id="O4" value="-79.1" spread="2.53"/>
                    <measurement group_id="O5" value="-74.9" spread="1.18"/>
                    <measurement group_id="O6" value="-82.4" spread="1.76"/>
                    <measurement group_id="O7" value="-59.4" spread="2.81"/>
                    <measurement group_id="O8" value="-66.7" spread="2.32"/>
                    <measurement group_id="O9" value="-52.5" spread="2.51"/>
                    <measurement group_id="O10" value="-62.7" spread="2.69"/>
                    <measurement group_id="O11" value="-77.3" spread="1.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cohort 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>-28.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.85</ci_lower_limit>
            <ci_upper_limit>-22.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Cohort 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>-25.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-31.23</ci_lower_limit>
            <ci_upper_limit>-19.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Cohort 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>-29.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.15</ci_lower_limit>
            <ci_upper_limit>-25.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Cohort 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>-22.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-26.36</ci_lower_limit>
            <ci_upper_limit>-18.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Cohort 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>-17.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.54</ci_lower_limit>
            <ci_upper_limit>-13.50</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Cohort 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>-15.51</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.53</ci_lower_limit>
            <ci_upper_limit>-11.49</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O9</group_id>
            </group_id_list>
            <groups_desc>Cohort 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>-9.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.97</ci_lower_limit>
            <ci_upper_limit>-5.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O10</group_id>
            </group_id_list>
            <groups_desc>Cohort 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0221</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>-4.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.19</ci_lower_limit>
            <ci_upper_limit>-0.76</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O11</group_id>
            </group_id_list>
            <groups_desc>Cohort 5</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>-35.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-38.89</ci_lower_limit>
            <ci_upper_limit>-31.87</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cohort 5</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>-27.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-30.60</ci_lower_limit>
            <ci_upper_limit>-23.57</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Cohort 5</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>-31.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-34.77</ci_lower_limit>
            <ci_upper_limit>-27.75</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Urine Uric Acid % Change (0-24h) (Aeur, CB)</title>
        <description>Percentage (%) change from baseline in the amount of uric acid recovered in urine.</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Febuxostat 40 mg</title>
            <description>Days 7/14/21/28 Overall (Cohorts 1 through 5)</description>
          </group>
          <group group_id="O2">
            <title>Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohorts 1 through 5)</description>
          </group>
          <group group_id="O3">
            <title>RDEA3170 10 mg + Febuxostat 40 mg</title>
            <description>Days 7/14/21/28 Overall (Cohorts 1 and 5)</description>
          </group>
          <group group_id="O4">
            <title>RDEA3170 10 mg + Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohort 1)</description>
          </group>
          <group group_id="O5">
            <title>RDEA3170 15 mg + Febuxostat 40 mg</title>
            <description>Days 7/14/21/28 Overall (Cohorts 2 and 5)</description>
          </group>
          <group group_id="O6">
            <title>RDEA3170 15 mg + Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohort 2)</description>
          </group>
          <group group_id="O7">
            <title>RDEA3170 5 mg + Febuxostat 40 mg</title>
            <description>Days 14/21 Overall (Cohort 3)</description>
          </group>
          <group group_id="O8">
            <title>RDEA3170 5 mg + Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohort 3)</description>
          </group>
          <group group_id="O9">
            <title>RDEA3170 2.5 mg + Febuxostat 40 mg</title>
            <description>Days 14/21 Overall (Cohort 4)</description>
          </group>
          <group group_id="O10">
            <title>RDEA3170 2.5 mg + Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohort 4)</description>
          </group>
          <group group_id="O11">
            <title>RDEA3170 20 mg + Febuxostat 40 mg</title>
            <description>Days 14/21 Overall (Cohort 5)</description>
          </group>
        </group_list>
        <measure>
          <title>Urine Uric Acid % Change (0-24h) (Aeur, CB)</title>
          <description>Percentage (%) change from baseline in the amount of uric acid recovered in urine.</description>
          <units>Percentage (%)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="22"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="10"/>
                <count group_id="O9" value="11"/>
                <count group_id="O10" value="11"/>
                <count group_id="O11" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-48.6" spread="1.71"/>
                    <measurement group_id="O2" value="-60.3" spread="1.58"/>
                    <measurement group_id="O3" value="-23.7" spread="5.56"/>
                    <measurement group_id="O4" value="-36.6" spread="6.75"/>
                    <measurement group_id="O5" value="-22.9" spread="4.15"/>
                    <measurement group_id="O6" value="-44.4" spread="5.57"/>
                    <measurement group_id="O7" value="-26.2" spread="8.28"/>
                    <measurement group_id="O8" value="-39.2" spread="5.95"/>
                    <measurement group_id="O9" value="-40.2" spread="4.07"/>
                    <measurement group_id="O10" value="-61.1" spread="2.16"/>
                    <measurement group_id="O11" value="-14.2" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cohort 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>24.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>12.57</ci_lower_limit>
            <ci_upper_limit>35.98</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Cohort 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0013</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>20.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.38</ci_lower_limit>
            <ci_upper_limit>31.79</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Cohort 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>23.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.23</ci_lower_limit>
            <ci_upper_limit>33.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Cohort 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0008</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>18.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.30</ci_lower_limit>
            <ci_upper_limit>28.44</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Cohort 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0101</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>18.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.86</ci_lower_limit>
            <ci_upper_limit>32.79</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Cohort 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0055</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>20.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.56</ci_lower_limit>
            <ci_upper_limit>34.48</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O9</group_id>
            </group_id_list>
            <groups_desc>Cohort 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0065</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>10.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.13</ci_lower_limit>
            <ci_upper_limit>17.59</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O10</group_id>
            </group_id_list>
            <groups_desc>Cohort 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.6140</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>1.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.37</ci_lower_limit>
            <ci_upper_limit>8.94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O11</group_id>
            </group_id_list>
            <groups_desc>Cohort 5</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>30.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>15.62</ci_lower_limit>
            <ci_upper_limit>46.04</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cohort 5</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0019</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>24.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.63</ci_lower_limit>
            <ci_upper_limit>39.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Cohort 5</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0009</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>26.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.59</ci_lower_limit>
            <ci_upper_limit>41.11</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)</title>
        <description>Percentage (%) change from baseline in renal clearance of uric acid.</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Febuxostat 40 mg</title>
            <description>Days 7/14/21/28 Overall (Cohorts 1 through 5)</description>
          </group>
          <group group_id="O2">
            <title>Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohorts 1 through 5)</description>
          </group>
          <group group_id="O3">
            <title>RDEA3170 10 mg + Febuxostat 40 mg</title>
            <description>Days 7/14/21/28 Overall (Cohorts 1 and 5)</description>
          </group>
          <group group_id="O4">
            <title>RDEA3170 10 mg + Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohort 1)</description>
          </group>
          <group group_id="O5">
            <title>RDEA3170 15 mg + Febuxostat 40 mg</title>
            <description>Days 7/14/21/28 Overall (Cohorts 2 and 5)</description>
          </group>
          <group group_id="O6">
            <title>RDEA3170 15 mg + Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohort 2)</description>
          </group>
          <group group_id="O7">
            <title>RDEA3170 5 mg + Febuxostat 40 mg</title>
            <description>Days 14/21 Overall (Cohort 3)</description>
          </group>
          <group group_id="O8">
            <title>RDEA3170 5 mg + Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohort 3)</description>
          </group>
          <group group_id="O9">
            <title>RDEA3170 2.5 mg + Febuxostat 40 mg</title>
            <description>Days 14/21 Overall (Cohort 4)</description>
          </group>
          <group group_id="O10">
            <title>RDEA3170 2.5 mg + Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohort 4)</description>
          </group>
          <group group_id="O11">
            <title>RDEA3170 20 mg + Febuxostat 40 mg</title>
            <description>Days 14/21 Overall (Cohort 5)</description>
          </group>
        </group_list>
        <measure>
          <title>Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)</title>
          <description>Percentage (%) change from baseline in renal clearance of uric acid.</description>
          <units>Percentage (%)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="20"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="10"/>
                <count group_id="O9" value="10"/>
                <count group_id="O10" value="10"/>
                <count group_id="O11" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.2" spread="2.53"/>
                    <measurement group_id="O2" value="-18.8" spread="2.52"/>
                    <measurement group_id="O3" value="125" spread="17.4"/>
                    <measurement group_id="O4" value="153" spread="30.5"/>
                    <measurement group_id="O5" value="157" spread="15.9"/>
                    <measurement group_id="O6" value="172" spread="30.0"/>
                    <measurement group_id="O7" value="58.7" spread="15.7"/>
                    <measurement group_id="O8" value="68.4" spread="24.7"/>
                    <measurement group_id="O9" value="20.9" spread="10.1"/>
                    <measurement group_id="O10" value="0.011" spread="7.36"/>
                    <measurement group_id="O11" value="223" spread="47.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cohort 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>139.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>93.92</ci_lower_limit>
            <ci_upper_limit>184.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Cohort 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>174.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>125.52</ci_lower_limit>
            <ci_upper_limit>233.42</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Cohort 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>168.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>123.13</ci_lower_limit>
            <ci_upper_limit>212.93</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Cohort 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>188.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>138.04</ci_lower_limit>
            <ci_upper_limit>239.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Cohort 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0005</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>70.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>33.74</ci_lower_limit>
            <ci_upper_limit>107.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Cohort 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>91.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>54.81</ci_lower_limit>
            <ci_upper_limit>128.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O9</group_id>
            </group_id_list>
            <groups_desc>Cohort 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>40.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>25.17</ci_lower_limit>
            <ci_upper_limit>55.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O10</group_id>
            </group_id_list>
            <groups_desc>Cohort 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0350</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>15.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.20</ci_lower_limit>
            <ci_upper_limit>30.71</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O11</group_id>
            </group_id_list>
            <groups_desc>Cohort 5</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>236.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>178.29</ci_lower_limit>
            <ci_upper_limit>293.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cohort 5</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>146.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>90.40</ci_lower_limit>
            <ci_upper_limit>202.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Cohort 5</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>176.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>120.77</ci_lower_limit>
            <ci_upper_limit>232.38</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)</title>
        <description>Percentage (%) change from baseline in fractional excretion of uric acid.</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Febuxostat 40 mg</title>
            <description>Days 7/14/21/28 Overall (Cohorts 1 through 5)</description>
          </group>
          <group group_id="O2">
            <title>Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohorts 1 through 5)</description>
          </group>
          <group group_id="O3">
            <title>RDEA3170 10 mg + Febuxostat 40 mg</title>
            <description>Days 7/14/21/28 Overall (Cohorts 1 and 5)</description>
          </group>
          <group group_id="O4">
            <title>RDEA3170 10 mg + Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohort 1)</description>
          </group>
          <group group_id="O5">
            <title>RDEA3170 15 mg + Febuxostat 40 mg</title>
            <description>Days 7/14/21/28 Overall (Cohorts 2 and 5)</description>
          </group>
          <group group_id="O6">
            <title>RDEA3170 15 mg + Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohort 2)</description>
          </group>
          <group group_id="O7">
            <title>RDEA3170 5 mg + Febuxostat 40 mg</title>
            <description>Days 14/21 Overall (Cohort 3)</description>
          </group>
          <group group_id="O8">
            <title>RDEA3170 5 mg + Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohort 3)</description>
          </group>
          <group group_id="O9">
            <title>RDEA3170 2.5 mg + Febuxostat 40 mg</title>
            <description>Days 14/21 Overall (Cohort 4)</description>
          </group>
          <group group_id="O10">
            <title>RDEA3170 2.5 mg + Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohort 4)</description>
          </group>
          <group group_id="O11">
            <title>RDEA3170 20 mg + Febuxostat 40 mg</title>
            <description>Days 14/21 Overall (Cohort 5)</description>
          </group>
        </group_list>
        <measure>
          <title>Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)</title>
          <description>Percentage (%) change from baseline in fractional excretion of uric acid.</description>
          <units>Percentage (%)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="19"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="7"/>
                <count group_id="O9" value="10"/>
                <count group_id="O10" value="10"/>
                <count group_id="O11" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.6" spread="1.82"/>
                    <measurement group_id="O2" value="-20.8" spread="2.62"/>
                    <measurement group_id="O3" value="100" spread="13.4"/>
                    <measurement group_id="O4" value="155" spread="32.4"/>
                    <measurement group_id="O5" value="133" spread="12.2"/>
                    <measurement group_id="O6" value="152" spread="26.2"/>
                    <measurement group_id="O7" value="46.6" spread="9.36"/>
                    <measurement group_id="O8" value="54.8" spread="20.5"/>
                    <measurement group_id="O9" value="15.2" spread="9.30"/>
                    <measurement group_id="O10" value="4.73" spread="6.15"/>
                    <measurement group_id="O11" value="162" spread="23.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cohort 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>135.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>93.33</ci_lower_limit>
            <ci_upper_limit>178.32</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Cohort 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>178.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>129.25</ci_lower_limit>
            <ci_upper_limit>227.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Cohort 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>163.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>120.80</ci_lower_limit>
            <ci_upper_limit>207.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Cohort 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>169.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>122.82</ci_lower_limit>
            <ci_upper_limit>217.03</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Cohort 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0007</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>59.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>28.85</ci_lower_limit>
            <ci_upper_limit>90.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Cohort 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>73.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>42.79</ci_lower_limit>
            <ci_upper_limit>104.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O9</group_id>
            </group_id_list>
            <groups_desc>Cohort 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>33.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>21.21</ci_lower_limit>
            <ci_upper_limit>46.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O10</group_id>
            </group_id_list>
            <groups_desc>Cohort 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>27.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.58</ci_lower_limit>
            <ci_upper_limit>39.58</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O11</group_id>
            </group_id_list>
            <groups_desc>Cohort 5</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>188.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>152.55</ci_lower_limit>
            <ci_upper_limit>225.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cohort 5</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>116.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>81.76</ci_lower_limit>
            <ci_upper_limit>151.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Cohort 5</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The model included treatment and period as fixed effects and subject(s) as a random effect.</method_desc>
            <param_type>Geometric Least Squares mean Ratio</param_type>
            <param_value>151.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>116.59</ci_lower_limit>
            <ci_upper_limit>186.73</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Plasma Concentration (Cmax)</title>
        <description>Cmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma</description>
        <time_frame>Days 7 to 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RDEA3170 10 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohorts 1 and 5)</description>
          </group>
          <group group_id="O2">
            <title>RDEA3170 10 mg + Febuxostat 80 mg</title>
            <description>Overall (Cohort 1)</description>
          </group>
          <group group_id="O3">
            <title>RDEA3170 15 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohorts 2 and 5)</description>
          </group>
          <group group_id="O4">
            <title>RDEA3170 15 mg + Febuxostat 80 mg</title>
            <description>Overall (Cohort 2)</description>
          </group>
          <group group_id="O5">
            <title>RDEA3170 5 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohort 3)</description>
          </group>
          <group group_id="O6">
            <title>RDEA3170 5 mg + Febuxostat 80 mg</title>
            <description>Overall (Cohort 3)</description>
          </group>
          <group group_id="O7">
            <title>RDEA3170 2.5 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohort 4)</description>
          </group>
          <group group_id="O8">
            <title>RDEA3170 2.5 mg + Febuxostat 80 mg</title>
            <description>Overall (Cohort 4)</description>
          </group>
          <group group_id="O9">
            <title>RDEA3170 20 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohort 5)</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax)</title>
          <description>Cmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma</description>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="12"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="12"/>
                <count group_id="O9" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.5" lower_limit="12.9" upper_limit="18.6"/>
                    <measurement group_id="O2" value="16.1" lower_limit="12.6" upper_limit="20.6"/>
                    <measurement group_id="O3" value="21.2" lower_limit="18.0" upper_limit="25.1"/>
                    <measurement group_id="O4" value="20.4" lower_limit="15.8" upper_limit="26.2"/>
                    <measurement group_id="O5" value="7.20" lower_limit="5.55" upper_limit="9.34"/>
                    <measurement group_id="O6" value="7.54" lower_limit="5.69" upper_limit="9.99"/>
                    <measurement group_id="O7" value="3.45" lower_limit="2.63" upper_limit="4.52"/>
                    <measurement group_id="O8" value="3.37" lower_limit="2.42" upper_limit="4.68"/>
                    <measurement group_id="O9" value="26.1" lower_limit="20.1" upper_limit="33.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time of Occurrence of Maximum Observed Concentration (Tmax)</title>
        <description>Tmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma</description>
        <time_frame>Days 7 to 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RDEA3170 10 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohorts 1 and 5)</description>
          </group>
          <group group_id="O2">
            <title>RDEA3170 10 mg + Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohort 1)</description>
          </group>
          <group group_id="O3">
            <title>RDEA3170 15 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohorts 2 and 5)</description>
          </group>
          <group group_id="O4">
            <title>RDEA3170 15 mg + Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohort 2)</description>
          </group>
          <group group_id="O5">
            <title>RDEA3170 5 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohort 3)</description>
          </group>
          <group group_id="O6">
            <title>RDEA3170 5 mg + Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohort 3)</description>
          </group>
          <group group_id="O7">
            <title>RDEA3170 2.5 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohort 4)</description>
          </group>
          <group group_id="O8">
            <title>RDEA3170 2.5 mg + Febuxostat 80 mg</title>
            <description>Days 14/21 Overall (Cohort 4)</description>
          </group>
          <group group_id="O9">
            <title>RDEA3170 20 mg + Febuxostat 40 mg</title>
            <description>Days 14/21 Overall (Cohort 5)</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Occurrence of Maximum Observed Concentration (Tmax)</title>
          <description>Tmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma</description>
          <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="24"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="12"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="12"/>
                <count group_id="O9" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" lower_limit="1.50" upper_limit="10.0"/>
                    <measurement group_id="O2" value="3.00" lower_limit="1.00" upper_limit="12.0"/>
                    <measurement group_id="O3" value="3.00" lower_limit="1.50" upper_limit="8.00"/>
                    <measurement group_id="O4" value="4.00" lower_limit="2.00" upper_limit="6.00"/>
                    <measurement group_id="O5" value="3.50" lower_limit="2.00" upper_limit="6.00"/>
                    <measurement group_id="O6" value="4.00" lower_limit="1.50" upper_limit="12.0"/>
                    <measurement group_id="O7" value="3.50" lower_limit="1.50" upper_limit="8.00"/>
                    <measurement group_id="O8" value="2.50" lower_limit="1.00" upper_limit="10.0"/>
                    <measurement group_id="O9" value="3.00" lower_limit="1.50" upper_limit="6.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)</title>
        <description>AUC 0-24 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma</description>
        <time_frame>Days 7 to 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RDEA3170 10 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohorts 1 and 5)</description>
          </group>
          <group group_id="O2">
            <title>RDEA3170 10 mg + Febuxostat 80 mg</title>
            <description>Overall (Cohort 1)</description>
          </group>
          <group group_id="O3">
            <title>RDEA3170 15 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohorts 2 and 5)</description>
          </group>
          <group group_id="O4">
            <title>RDEA3170 15 mg + Febuxostat 80 mg</title>
            <description>Overall (Cohort 2)</description>
          </group>
          <group group_id="O5">
            <title>RDEA3170 5 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohort 3)</description>
          </group>
          <group group_id="O6">
            <title>RDEA3170 5 mg + Febuxostat 80 mg</title>
            <description>Overall (Cohort 3)</description>
          </group>
          <group group_id="O7">
            <title>RDEA3170 2.5 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohort 4)</description>
          </group>
          <group group_id="O8">
            <title>RDEA3170 2.5 mg + Febuxostat 80 mg</title>
            <description>Overall (Cohort 4)</description>
          </group>
          <group group_id="O9">
            <title>RDEA3170 20 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohort 5)</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)</title>
          <description>AUC 0-24 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma</description>
          <units>ng·hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="12"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="12"/>
                <count group_id="O9" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123" lower_limit="104" upper_limit="146"/>
                    <measurement group_id="O2" value="138" lower_limit="106" upper_limit="179"/>
                    <measurement group_id="O3" value="186" lower_limit="164" upper_limit="212"/>
                    <measurement group_id="O4" value="225" lower_limit="182" upper_limit="278"/>
                    <measurement group_id="O5" value="62.2" lower_limit="47.8" upper_limit="80.8"/>
                    <measurement group_id="O6" value="57.6" lower_limit="46.8" upper_limit="70.9"/>
                    <measurement group_id="O7" value="28.0" lower_limit="21.2" upper_limit="36.9"/>
                    <measurement group_id="O8" value="27.4" lower_limit="19.7" upper_limit="38.1"/>
                    <measurement group_id="O9" value="216" lower_limit="173" upper_limit="270"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)</title>
        <description>AUC last of multiple-dose RDEA3170 administered in combination with febuxostat from plasma</description>
        <time_frame>Days 7 to 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RDEA3170 10 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohorts 1 and 5)</description>
          </group>
          <group group_id="O2">
            <title>RDEA3170 10 mg + Febuxostat 80 mg</title>
            <description>Overall (Cohort 1)</description>
          </group>
          <group group_id="O3">
            <title>RDEA3170 15 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohorts 2 and 5)</description>
          </group>
          <group group_id="O4">
            <title>RDEA3170 15 mg + Febuxostat 80 mg</title>
            <description>Overall (Cohort 2)</description>
          </group>
          <group group_id="O5">
            <title>RDEA3170 5 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohort 3)</description>
          </group>
          <group group_id="O6">
            <title>RDEA3170 5 mg + Febuxostat 80 mg</title>
            <description>Overall (Cohort 3)</description>
          </group>
          <group group_id="O7">
            <title>RDEA3170 2.5 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohort 4)</description>
          </group>
          <group group_id="O8">
            <title>RDEA3170 2.5 mg + Febuxostat 80 mg</title>
            <description>Overall (Cohort 4)</description>
          </group>
          <group group_id="O9">
            <title>RDEA3170 20 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohort 5)</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)</title>
          <description>AUC last of multiple-dose RDEA3170 administered in combination with febuxostat from plasma</description>
          <units>ng·hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="12"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="12"/>
                <count group_id="O9" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123" lower_limit="104" upper_limit="146"/>
                    <measurement group_id="O2" value="138" lower_limit="106" upper_limit="179"/>
                    <measurement group_id="O3" value="186" lower_limit="164" upper_limit="212"/>
                    <measurement group_id="O4" value="225" lower_limit="182" upper_limit="278"/>
                    <measurement group_id="O5" value="62.2" lower_limit="47.8" upper_limit="80.8"/>
                    <measurement group_id="O6" value="62.6" lower_limit="48.2" upper_limit="81.3"/>
                    <measurement group_id="O7" value="28.0" lower_limit="21.2" upper_limit="36.9"/>
                    <measurement group_id="O8" value="26.8" lower_limit="18.8" upper_limit="38.3"/>
                    <measurement group_id="O9" value="216" lower_limit="173" upper_limit="270"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Terminal Half-life (t1/2)</title>
        <description>t1/2 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma</description>
        <time_frame>Days 7 to 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RDEA3170 10 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohorts 1 and 5)</description>
          </group>
          <group group_id="O2">
            <title>RDEA3170 10 mg + Febuxostat 80 mg</title>
            <description>Overall (Cohort 1)</description>
          </group>
          <group group_id="O3">
            <title>RDEA3170 15 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohorts 2 and 5)</description>
          </group>
          <group group_id="O4">
            <title>RDEA3170 15 mg + Febuxostat 80 mg</title>
            <description>Overall (Cohort 2)</description>
          </group>
          <group group_id="O5">
            <title>RDEA3170 5 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohort 3)</description>
          </group>
          <group group_id="O6">
            <title>RDEA3170 5 mg + Febuxostat 80 mg</title>
            <description>Overall (Cohort 3)</description>
          </group>
          <group group_id="O7">
            <title>RDEA3170 2.5 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohort 4)</description>
          </group>
          <group group_id="O8">
            <title>RDEA3170 2.5 mg + Febuxostat 80 mg</title>
            <description>Overall (Cohort 4)</description>
          </group>
          <group group_id="O9">
            <title>RDEA3170 20 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohort 5)</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Terminal Half-life (t1/2)</title>
          <description>t1/2 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma</description>
          <units>hr</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="12"/>
                <count group_id="O6" value="11"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="12"/>
                <count group_id="O9" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.26" lower_limit="6.71" upper_limit="10.2"/>
                    <measurement group_id="O2" value="9.64" lower_limit="6.77" upper_limit="13.7"/>
                    <measurement group_id="O3" value="10.6" lower_limit="8.41" upper_limit="13.3"/>
                    <measurement group_id="O4" value="10.8" lower_limit="8.17" upper_limit="14.3"/>
                    <measurement group_id="O5" value="13.2" lower_limit="8.11" upper_limit="21.4"/>
                    <measurement group_id="O6" value="11.3" lower_limit="7.09" upper_limit="18.1"/>
                    <measurement group_id="O7" value="13.0" lower_limit="8.89" upper_limit="19.1"/>
                    <measurement group_id="O8" value="12.5" lower_limit="8.18" upper_limit="19.2"/>
                    <measurement group_id="O9" value="11.6" lower_limit="7.17" upper_limit="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Treatment-Emergent Adverse Events</title>
        <time_frame>10 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Febuxostat 40 mg</title>
            <description>Overall (Cohorts 1 through 5)</description>
          </group>
          <group group_id="O2">
            <title>Febuxostat 80 mg</title>
            <description>Overall (Cohorts 1 through 5)</description>
          </group>
          <group group_id="O3">
            <title>RDEA3170 10 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohorts 1 and 5)</description>
          </group>
          <group group_id="O4">
            <title>RDEA3170 10 mg + Febuxostat 80 mg</title>
            <description>Overall (Cohort 1)</description>
          </group>
          <group group_id="O5">
            <title>RDEA3170 15 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohorts 2 and 5)</description>
          </group>
          <group group_id="O6">
            <title>RDEA3170 15 mg + Febuxostat 80 mg</title>
            <description>Overall (Cohort 2)</description>
          </group>
          <group group_id="O7">
            <title>RDEA3170 5 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohort 3)</description>
          </group>
          <group group_id="O8">
            <title>RDEA3170 5 mg + Febuxostat 80 mg</title>
            <description>Overall (Cohort 3)</description>
          </group>
          <group group_id="O9">
            <title>RDEA3170 2.5 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohort 4)</description>
          </group>
          <group group_id="O10">
            <title>RDEA3170 2.5 mg + Febuxostat 80 mg</title>
            <description>Overall (Cohort 4)</description>
          </group>
          <group group_id="O11">
            <title>RDEA3170 20 mg + Febuxostat 40 mg</title>
            <description>Overall (Cohort 5)</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Treatment-Emergent Adverse Events</title>
          <units>Number of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="23"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="12"/>
                <count group_id="O9" value="12"/>
                <count group_id="O10" value="13"/>
                <count group_id="O11" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="1"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>10 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Febuxostat 40 mg</title>
        </group>
        <group group_id="E2">
          <title>Febuxostat 80 mg</title>
        </group>
        <group group_id="E3">
          <title>Overall RDEA3170 + Febuxostat Combination</title>
        </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="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA Version 17.0</default_vocab>
        <default_assessment>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="3" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tympanic Membrane Hyperaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Aphthous Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hepatitis Acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Herpes Simplex</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Excoriation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Hepatic Enzyme Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain In Extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Productive Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Throat Irritation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </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>PI shall submit a copy of the Publication to Sponsor for review at least 45 days prior to its proposed submission. Sponsor reserves the right to delay any such publication for an additional period of 60 days. Upon Sponsor's request, PI agrees to delete from the proposed publication any Confidential Information. PI agrees not to release any publication without the prior written permission of Sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jesse Hall, MD</name_or_title>
      <organization>Study Information Center AstraZeneca</organization>
      <phone>+1 877-240-9479</phone>
      <email>information.center@astrazeneca.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/NCT02246673
org study id: RDEA3170-204
nct id: NCT02246673
lead sponsor: 
has dmc: No
This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic
      (PD) effects and safety of RDEA3170 administered in combination with febuxostat compared to
      febuxostat administered alone in adult subjects with gout.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Serum Urate Maximum Percentage (%) Change (Emax, CB)
time frame: 28 days
description: Maximum observed percentage (%) change from baseline in serum urate concentrations.
measure: Urine Uric Acid % Change (0-24h) (Aeur, CB)
time frame: 28 days
description: Percentage (%) change from baseline in the amount of uric acid recovered in urine.
measure: Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)
time frame: 28 days
description: Percentage (%) change from baseline in renal clearance of uric acid.
measure: Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)
time frame: 28 days
description: Percentage (%) change from baseline in fractional excretion of uric acid.
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: Days 7 to 28
description: Cmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
measure: Time of Occurrence of Maximum Observed Concentration (Tmax)
time frame: Days 7 to 28
description: Tmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
measure: Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
time frame: Days 7 to 28
description: AUC 0-24 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
measure: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
time frame: Days 7 to 28
description: AUC last of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
measure: Apparent Terminal Half-life (t1/2)
time frame: Days 7 to 28
description: t1/2 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
measure: Incidence of Treatment-Emergent Adverse Events
time frame: 10 weeks
arm group label: RDEA3170 10 mg
arm group type: Experimental
description: Once daily (qd) with febuxostat 40mg (qd) for 7 days, and with febuxostat 80 mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.
arm group label: RDEA3170 15 mg
arm group type: Experimental
description: Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.
arm group label: RDEA3170 5 mg
arm group type: Experimental
description: Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.
arm group label: RDEA3170 2.5 mg
arm group type: Experimental
description: Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.
intervention type: Drug
intervention name: RDEA3170 15 mg
arm group label: RDEA3170 15 mg
intervention type: Drug
intervention name: RDEA3170 10 mg
arm group label: RDEA3170 10 mg
intervention type: Drug
intervention name: RDEA3170 2.5
arm group label: RDEA3170 2.5 mg
intervention type: Drug
intervention name: RDEA3170 5 mg
arm group label: RDEA3170 15 mg
intervention type: Drug
intervention name: Febuxostat 40 mg
arm group label: RDEA3170 10 mg
arm group label: RDEA3170 15 mg
arm group label: RDEA3170 2.5 mg
arm group label: RDEA3170 5 mg
intervention type: Drug
intervention name: Febuxostat 80 mg
arm group label: RDEA3170 10 mg
arm group label: RDEA3170 15 mg
arm group label: RDEA3170 2.5 mg
arm group label: RDEA3170 5 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: J. Hall
role: Study Director
affiliation: Ardea Biosciences, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Gout
mesh term: Febuxostat
mesh term: Verinurad
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 