<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/NCT02219516</url>
  </required_header>
  <id_info>
    <org_study_id>RDEA3170-108</org_study_id>
    <nct_id>NCT02219516</nct_id>
  </id_info>
  <brief_title>Mild, Moderate and Severe Renal Impairment Study</brief_title>
  <official_title>A Phase 1, Single-Dose, Open Label, Pharmacokinetic and Pharmacodynamic Study of RDEA3170 in Adult Male Subjects With Mild, Moderate, and Severe Renal Impairment</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 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD)&#xD;
      study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2014</start_date>
  <completion_date type="Actual">May 13, 2016</completion_date>
  <primary_completion_date type="Actual">October 30, 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose</time_frame>
    <description>Cmax following a single administration of RDEA3170 to subjects with various degrees of renal function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of Occurrence of Maximum Observed Concentration (Tmax)</measure>
    <time_frame>Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose</time_frame>
    <description>Tmax following a single administration of RDEA3170 to subjects with various degrees of renal function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)</measure>
    <time_frame>Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose</time_frame>
    <description>AUC last following a single administration of RDEA3170 to subjects with various degrees of renal function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞)</measure>
    <time_frame>Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose</time_frame>
    <description>AUC∞ following a single administration of RDEA3170 to subjects with various degrees of renal function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Terminal Half-life (t1/2)</measure>
    <time_frame>Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose</time_frame>
    <description>t1/2 following a single administration of RDEA3170 to subjects with various degrees of renal function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72)</measure>
    <time_frame>Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose</time_frame>
    <description>CLNR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Body Clearance Corrected for Bioavailability (CL/F)</measure>
    <time_frame>Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose</time_frame>
    <description>CL/F following a single administration of RDEA3170 to subjects with various degrees of renal function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72)</measure>
    <time_frame>Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose</time_frame>
    <description>CLR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>5 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine</measure>
    <time_frame>Screening, Day -1 ( -24, -21, -18, -and -12 hours predose), and Day 1 (within 30 minutes prior to dosing and at 3, 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours postdose)</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Gout</condition>
  <arm_group>
    <arm_group_label>Cohort 1: Mild renal impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RDEA3170 15 mg once daily fasted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: Moderate renal impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RDEA3170 15 mg once daily fasted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3: Severe renal impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RDEA3170 15 mg once daily fasted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4: Control subjects with normal renal function</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RDEA3170 15 mg once daily fasted</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RDEA3170</intervention_name>
    <arm_group_label>Cohort 1: Mild renal impairment</arm_group_label>
    <arm_group_label>Cohort 2: Moderate renal impairment</arm_group_label>
    <arm_group_label>Cohort 3: Severe renal impairment</arm_group_label>
    <arm_group_label>Cohort 4: Control subjects with normal renal function</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40&#xD;
             kg/m2.&#xD;
&#xD;
          -  Subject with renal impairment, as determined at Screening, with creatinine clearance&#xD;
             as calculated by the Cockcroft-Gault formula of 60 to &lt; 90 mL/min (mild impairment),&#xD;
             30 to &lt; 60 mL/min (moderate impairment), or 15 to &lt; 30 mL/min (severe impairment), or&#xD;
             a matched control subject (by age and body mass index) with a creatinine clearance of&#xD;
             ≥ 90 mL/min.&#xD;
&#xD;
          -  Subject has a Screening serum urate level ≥ 4.5 mg/dL and ≤ 10 mg/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a history or clinical manifestations of significant metabolic,&#xD;
             hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic,&#xD;
             renal, urological, or psychiatric disorders.&#xD;
&#xD;
          -  Subject has a history or suspicion of kidney stones.&#xD;
&#xD;
          -  Subject has a history of asthma.&#xD;
&#xD;
          -  Subject has undergone major surgery within 3 months prior to Day 1.&#xD;
&#xD;
          -  Subject has donated blood or experienced significant blood loss (&gt; 450 mL) within 12&#xD;
             weeks prior to Day 1 or gave a plasma donation&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>J. Hall, MD</last_name>
    <role>Study Director</role>
    <affiliation>Ardea Biosciences, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <results_first_submitted>March 14, 2017</results_first_submitted>
  <results_first_submitted_qc>March 14, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 25, 2017</results_first_posted>
  <last_update_submitted>March 14, 2017</last_update_submitted>
  <last_update_submitted_qc>March 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 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>Renal Insufficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Verinurad</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>31 subjects were randomized</recruitment_details>
      <pre_assignment_details>Thirty-one subjects were randomized to 1 of 4 cohorts. Cohort 1: mild renal impairment; Cohort 2: moderate renal impairment; Cohort 3: severe renal impairment and Cohort 4: normal renal function. All 31 subjects received a single dose of 15 mg RDEA3170 (6 x 2.5 mg) in the fasted state.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1: Mild Renal Impairment + RDEA3170 15 mg</title>
          <description>Mild Renal Impairment (eCrCl of 60 to &lt; 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted</description>
        </group>
        <group group_id="P2">
          <title>Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg</title>
          <description>Moderate Renal Impairment (eCrCl of 30 to &lt; 60 mL/min) + RDEA3170 15 mg qd fasted</description>
        </group>
        <group group_id="P3">
          <title>Cohort 3: Severe Renal Impairment + RDEA3170 15 mg</title>
          <description>Severe Renal Impairment (eCrCl of 15 to &lt; 30 mL/min) + RDEA3170 15 mg qd fasted</description>
        </group>
        <group group_id="P4">
          <title>Cohort 4: Normal Renal Function + RDEA3170 15 mg</title>
          <description>Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</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_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1: Mild Renal Impairment + RDEA3170 15 mg</title>
          <description>Mild Renal Impairment (eCrCl of 60 to &lt; 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted</description>
        </group>
        <group group_id="B2">
          <title>Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg</title>
          <description>Moderate Renal Impairment (eCrCl of 30 to &lt; 60 mL/min) + RDEA3170 15 mg qd fasted</description>
        </group>
        <group group_id="B3">
          <title>Cohort 3: Severe Renal Impairment + RDEA3170 15 mg</title>
          <description>Severe Renal Impairment (eCrCl of 15 to &lt; 30 mL/min) + RDEA3170 15 mg qd fasted</description>
        </group>
        <group group_id="B4">
          <title>Cohort 4: Normal Renal Function + RDEA3170 15 mg</title>
          <description>Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted</description>
        </group>
        <group group_id="B5">
          <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="8"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="7"/>
            <count group_id="B4" value="8"/>
            <count group_id="B5" value="31"/>
          </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="63" spread="6.4"/>
                    <measurement group_id="B2" value="67" spread="14.9"/>
                    <measurement group_id="B3" value="58" spread="11.1"/>
                    <measurement group_id="B4" value="56" spread="4.7"/>
                    <measurement group_id="B5" value="61" spread="9.3"/>
                  </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_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Treatment-Emergent Adverse Events</title>
        <time_frame>5 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Mild Renal Impairment + RDEA3170 15 mg</title>
            <description>Mild Renal Impairment (eCrCl of 60 to &lt; 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg</title>
            <description>Moderate Renal Impairment (eCrCl of 30 to &lt; 60 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: Severe Renal Impairment + RDEA3170 15 mg</title>
            <description>Severe Renal Impairment (eCrCl of 15 to &lt; 30 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: Normal Renal Function + RDEA3170 15 mg</title>
            <description>Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted</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="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine</title>
        <time_frame>Screening, Day -1 ( -24, -21, -18, -and -12 hours predose), and Day 1 (within 30 minutes prior to dosing and at 3, 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours postdose)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Mild Renal Impairment + RDEA3170 15 mg</title>
            <description>Mild Renal Impairment (eCrCl of 60 to &lt; 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg</title>
            <description>Moderate Renal Impairment (eCrCl of 30 to &lt; 60 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: Severe Renal Impairment + RDEA3170 15 mg</title>
            <description>Severe Renal Impairment (eCrCl of 15 to &lt; 30 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: Normal Renal Function + RDEA3170 15 mg</title>
            <description>Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine</title>
          <units>Maximum Percentage (%) Change</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serum Urate Maximum % Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36.9" spread="4.79"/>
                    <measurement group_id="O2" value="-20.5" spread="2.62"/>
                    <measurement group_id="O3" value="-12.6" spread="2.62"/>
                    <measurement group_id="O4" value="-38.3" spread="5.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Uric Acid % Change (0-24h)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118" spread="25.3"/>
                    <measurement group_id="O2" value="69.3" spread="19.0"/>
                    <measurement group_id="O3" value="72.5" spread="17.1"/>
                    <measurement group_id="O4" value="85.2" spread="15.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renal Clearance of Uric Acid % Change (0-24h)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="222" spread="50.5"/>
                    <measurement group_id="O2" value="96.7" spread="11.9"/>
                    <measurement group_id="O3" value="82.9" spread="16.6"/>
                    <measurement group_id="O4" value="163" spread="30.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fract. Excretion of Uric Acid % Change (0-24h)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="206" spread="44.9"/>
                    <measurement group_id="O2" value="89.6" spread="24.1"/>
                    <measurement group_id="O3" value="54.5" spread="17.0"/>
                    <measurement group_id="O4" value="159" spread="28.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Uric Acid % Change (24-48h)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.49" spread="6.68"/>
                    <measurement group_id="O2" value="4.18" spread="9.89"/>
                    <measurement group_id="O3" value="28.3" spread="11.2"/>
                    <measurement group_id="O4" value="-1.54" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Uric Acid % Change (48-72h)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.1" spread="7.63"/>
                    <measurement group_id="O2" value="-16.0" spread="11.5"/>
                    <measurement group_id="O3" value="6.02" spread="20.2"/>
                    <measurement group_id="O4" value="-20.8" spread="9.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renal Clearance of Uric Acid % Change (24-48h)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.1" spread="12.9"/>
                    <measurement group_id="O2" value="25.4" spread="9.40"/>
                    <measurement group_id="O3" value="34.5" spread="9.17"/>
                    <measurement group_id="O4" value="31.9" spread="16.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renal Clearance of Uric Acid % Change (48-72h)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.39" spread="6.84"/>
                    <measurement group_id="O2" value="-0.439" spread="11.9"/>
                    <measurement group_id="O3" value="9.38" spread="21.5"/>
                    <measurement group_id="O4" value="-8.12" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fract. Excretion of Uric Acid % Change (24-48h)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.2" spread="10.8"/>
                    <measurement group_id="O2" value="28.7" spread="7.91"/>
                    <measurement group_id="O3" value="19.0" spread="4.89"/>
                    <measurement group_id="O4" value="27.8" spread="9.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fract. Excretion of Uric Acid % Change (48-72h)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.2" spread="9.43"/>
                    <measurement group_id="O2" value="4.18" spread="10.7"/>
                    <measurement group_id="O3" value="1.67" spread="4.01"/>
                    <measurement group_id="O4" value="2.27" spread="8.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Plasma Concentration (Cmax)</title>
        <description>Cmax following a single administration of RDEA3170 to subjects with various degrees of renal function</description>
        <time_frame>Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Mild Renal Impairment + RDEA3170 15 mg</title>
            <description>Mild Renal Impairment (eCrCl of 60 to &lt; 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg</title>
            <description>Moderate Renal Impairment (eCrCl of 30 to &lt; 60 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: Severe Renal Impairment + RDEA3170 15 mg</title>
            <description>Severe Renal Impairment (eCrCl of 15 to &lt; 30 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: Normal Renal Function + RDEA3170 15 mg</title>
            <description>Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax)</title>
          <description>Cmax following a single administration of RDEA3170 to subjects with various degrees of renal function</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="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.6" lower_limit="20.0" upper_limit="32.9"/>
                    <measurement group_id="O2" value="29.0" lower_limit="22.8" upper_limit="37.0"/>
                    <measurement group_id="O3" value="38.2" lower_limit="24.0" upper_limit="60.8"/>
                    <measurement group_id="O4" value="16.7" lower_limit="12.6" upper_limit="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Informal BE assessment using the conventional BE limits of 80% to 125%.</non_inferiority_desc>
            <param_type>Geometric Least Squares Mean Ratio (%)</param_type>
            <param_value>153</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>115</ci_lower_limit>
            <ci_upper_limit>203</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Informal BE assessment using the conventional BE limits of 80% to 125%.</non_inferiority_desc>
            <param_type>Geometric Least Squares Mean Ratio (%)</param_type>
            <param_value>173</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>131</ci_lower_limit>
            <ci_upper_limit>230</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Informal BE assessment using the conventional BE limits of 80% to 125%.</non_inferiority_desc>
            <param_type>Geometric Least Squares Mean Ratio (%)</param_type>
            <param_value>228</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>155</ci_lower_limit>
            <ci_upper_limit>336</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time of Occurrence of Maximum Observed Concentration (Tmax)</title>
        <description>Tmax following a single administration of RDEA3170 to subjects with various degrees of renal function</description>
        <time_frame>Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Mild Renal Impairment + RDEA3170 15 mg</title>
            <description>Mild Renal Impairment (eCrCl of 60 to &lt; 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg</title>
            <description>Moderate Renal Impairment (eCrCl of 30 to &lt; 60 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: Severe Renal Impairment + RDEA3170 15 mg</title>
            <description>Severe Renal Impairment (eCrCl of 15 to &lt; 30 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: Normal Renal Function + RDEA3170 15 mg</title>
            <description>Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Occurrence of Maximum Observed Concentration (Tmax)</title>
          <description>Tmax following a single administration of RDEA3170 to subjects with various degrees of renal function</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="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.50" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O2" value="3.00" lower_limit="1.50" upper_limit="5.00"/>
                    <measurement group_id="O3" value="2.00" lower_limit="1.50" upper_limit="4.00"/>
                    <measurement group_id="O4" value="2.50" lower_limit="0.500" upper_limit="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)</title>
        <description>AUC last following a single administration of RDEA3170 to subjects with various degrees of renal function</description>
        <time_frame>Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Mild Renal Impairment + RDEA3170 15 mg</title>
            <description>Mild Renal Impairment (eCrCl of 60 to &lt; 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg</title>
            <description>Moderate Renal Impairment (eCrCl of 30 to &lt; 60 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: Severe Renal Impairment + RDEA3170 15 mg</title>
            <description>Severe Renal Impairment (eCrCl of 15 to &lt; 30 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: Normal Renal Function + RDEA3170 15 mg</title>
            <description>Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted</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 following a single administration of RDEA3170 to subjects with various degrees of renal function</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="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="197" lower_limit="142" upper_limit="273"/>
                    <measurement group_id="O2" value="333" lower_limit="246" upper_limit="451"/>
                    <measurement group_id="O3" value="316" lower_limit="179" upper_limit="559"/>
                    <measurement group_id="O4" value="150" lower_limit="123" upper_limit="182"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Informal BE assessment using the conventional BE limits of 80% to 125%.</non_inferiority_desc>
            <param_type>Geometric Least Squares Mean Ratio (%)</param_type>
            <param_value>131</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>98.6</ci_lower_limit>
            <ci_upper_limit>174</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Informal BE assessment using the conventional BE limits of 80% to 125%.</non_inferiority_desc>
            <param_type>Geometric Least Squares Mean Ratio (%)</param_type>
            <param_value>222</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>171</ci_lower_limit>
            <ci_upper_limit>287</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Informal BE assessment using the conventional BE limits of 80% to 125%.</non_inferiority_desc>
            <param_type>Geometric Least Squares Mean Ratio (%)</param_type>
            <param_value>211</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>139</ci_lower_limit>
            <ci_upper_limit>319</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞)</title>
        <description>AUC∞ following a single administration of RDEA3170 to subjects with various degrees of renal function</description>
        <time_frame>Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Mild Renal Impairment + RDEA3170 15 mg</title>
            <description>Mild Renal Impairment (eCrCl of 60 to &lt; 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg</title>
            <description>Moderate Renal Impairment (eCrCl of 30 to &lt; 60 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: Severe Renal Impairment + RDEA3170 15 mg</title>
            <description>Severe Renal Impairment (eCrCl of 15 to &lt; 30 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: Normal Renal Function + RDEA3170 15 mg</title>
            <description>Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞)</title>
          <description>AUC∞ following a single administration of RDEA3170 to subjects with various degrees of renal function</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="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="201" lower_limit="144" upper_limit="279"/>
                    <measurement group_id="O2" value="402" lower_limit="225" upper_limit="634"/>
                    <measurement group_id="O3" value="372" lower_limit="209" upper_limit="663"/>
                    <measurement group_id="O4" value="162" lower_limit="120" upper_limit="218"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Informal BE assessment using the conventional BE limits of 80% to 125%.</non_inferiority_desc>
            <param_type>Geometric Least Squares Mean Ratio (%)</param_type>
            <param_value>124</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>88.8</ci_lower_limit>
            <ci_upper_limit>173</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Informal BE assessment using the conventional BE limits of 80% to 125%.</non_inferiority_desc>
            <param_type>Geometric Least Squares Mean Ratio (%)</param_type>
            <param_value>248</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>168</ci_lower_limit>
            <ci_upper_limit>366</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Informal BE assessment using the conventional BE limits of 80% to 125%.</non_inferiority_desc>
            <param_type>Geometric Least Squares Mean Ratio (%)</param_type>
            <param_value>230</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>146</ci_lower_limit>
            <ci_upper_limit>363</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Apparent Terminal Half-life (t1/2)</title>
        <description>t1/2 following a single administration of RDEA3170 to subjects with various degrees of renal function</description>
        <time_frame>Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Mild Renal Impairment + RDEA3170 15 mg</title>
            <description>Mild Renal Impairment (eCrCl of 60 to &lt; 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg</title>
            <description>Moderate Renal Impairment (eCrCl of 30 to &lt; 60 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: Severe Renal Impairment + RDEA3170 15 mg</title>
            <description>Severe Renal Impairment (eCrCl of 15 to &lt; 30 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: Normal Renal Function + RDEA3170 15 mg</title>
            <description>Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Terminal Half-life (t1/2)</title>
          <description>t1/2 following a single administration of RDEA3170 to subjects with various degrees of renal function</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="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.53" lower_limit="7.42" upper_limit="12.2"/>
                    <measurement group_id="O2" value="20.6" lower_limit="9.96" upper_limit="42.4"/>
                    <measurement group_id="O3" value="22.0" lower_limit="14.2" upper_limit="34.1"/>
                    <measurement group_id="O4" value="13.0" lower_limit="7.91" upper_limit="21.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72)</title>
        <description>CLNR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function</description>
        <time_frame>Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Mild Renal Impairment + RDEA3170 15 mg</title>
            <description>Mild Renal Impairment (eCrCl of 60 to &lt; 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg</title>
            <description>Moderate Renal Impairment (eCrCl of 30 to &lt; 60 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: Severe Renal Impairment + RDEA3170 15 mg</title>
            <description>Severe Renal Impairment (eCrCl of 15 to &lt; 30 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: Normal Renal Function + RDEA3170 15 mg</title>
            <description>Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
        </group_list>
        <measure>
          <title>Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72)</title>
          <description>CLNR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function</description>
          <units>L/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="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.9" lower_limit="53.9" upper_limit="104"/>
                    <measurement group_id="O2" value="44.5" lower_limit="33.0" upper_limit="59.9"/>
                    <measurement group_id="O3" value="47.2" lower_limit="26.6" upper_limit="83.5"/>
                    <measurement group_id="O4" value="98.6" lower_limit="80.9" upper_limit="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Informal BE assessment using the conventional BE limits of 80% to 125%.</non_inferiority_desc>
            <param_type>Geometric Least Squares Mean Ratio (%)</param_type>
            <param_value>76.0</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>57.1</ci_lower_limit>
            <ci_upper_limit>101</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Informal BE assessment using the conventional BE limits of 80% to 125%.</non_inferiority_desc>
            <param_type>Geometric Least Squares Mean Ratio (%)</param_type>
            <param_value>45.1</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>34.9</ci_lower_limit>
            <ci_upper_limit>58.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Informal BE assessment using the conventional BE limits of 80% to 125%.</non_inferiority_desc>
            <param_type>Geometric Least Squares Mean Ratio (%)</param_type>
            <param_value>47.8</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>31.5</ci_lower_limit>
            <ci_upper_limit>72.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Body Clearance Corrected for Bioavailability (CL/F)</title>
        <description>CL/F following a single administration of RDEA3170 to subjects with various degrees of renal function</description>
        <time_frame>Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Mild Renal Impairment + RDEA3170 15 mg</title>
            <description>Mild Renal Impairment (eCrCl of 60 to &lt; 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg</title>
            <description>Moderate Renal Impairment (eCrCl of 30 to &lt; 60 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: Severe Renal Impairment + RDEA3170 15 mg</title>
            <description>Severe Renal Impairment (eCrCl of 15 to &lt; 30 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: Normal Renal Function + RDEA3170 15 mg</title>
            <description>Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
        </group_list>
        <measure>
          <title>Total Body Clearance Corrected for Bioavailability (CL/F)</title>
          <description>CL/F following a single administration of RDEA3170 to subjects with various degrees of renal function</description>
          <units>L/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="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.8" lower_limit="53.7" upper_limit="104"/>
                    <measurement group_id="O2" value="37.3" lower_limit="23.7" upper_limit="58.9"/>
                    <measurement group_id="O3" value="40.3" lower_limit="22.6" upper_limit="71.7"/>
                    <measurement group_id="O4" value="92.6" lower_limit="68.7" upper_limit="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Informal BE assessment using the conventional BE limits of 80% to 125%.</non_inferiority_desc>
            <param_type>Geometric Least Squares Mean Ratio (%)</param_type>
            <param_value>80.8</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>57.9</ci_lower_limit>
            <ci_upper_limit>113</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Informal BE assessment using the conventional BE limits of 80% to 125%.</non_inferiority_desc>
            <param_type>Geometric Least Squares Mean Ratio (%)</param_type>
            <param_value>40.3</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>27.3</ci_lower_limit>
            <ci_upper_limit>59.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Informal BE assessment using the conventional BE limits of 80% to 125%.</non_inferiority_desc>
            <param_type>Geometric Least Squares Mean Ratio (%)</param_type>
            <param_value>43.5</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>27.5</ci_lower_limit>
            <ci_upper_limit>68.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72)</title>
        <description>CLR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function</description>
        <time_frame>Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Mild Renal Impairment + RDEA3170 15 mg</title>
            <description>Mild Renal Impairment (eCrCl of 60 to &lt; 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg</title>
            <description>Moderate Renal Impairment (eCrCl of 30 to &lt; 60 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: Severe Renal Impairment + RDEA3170 15 mg</title>
            <description>Severe Renal Impairment (eCrCl of 15 to &lt; 30 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: Normal Renal Function + RDEA3170 15 mg</title>
            <description>Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted</description>
          </group>
        </group_list>
        <measure>
          <title>Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72)</title>
          <description>CLR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function</description>
          <units>mL/min</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="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.9" lower_limit="8.16" upper_limit="20.4"/>
                    <measurement group_id="O2" value="7.87" lower_limit="3.36" upper_limit="18.4"/>
                    <measurement group_id="O3" value="2.86" lower_limit="1.84" upper_limit="4.45"/>
                    <measurement group_id="O4" value="13.5" lower_limit="9.03" upper_limit="20.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Informal BE assessment using the conventional BE limits of 80% to 125%.</non_inferiority_desc>
            <param_type>Geometric Least Squares Mean Ratio (%)</param_type>
            <param_value>95.4</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>60.6</ci_lower_limit>
            <ci_upper_limit>150</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Informal BE assessment using the conventional BE limits of 80% to 125%.</non_inferiority_desc>
            <param_type>Geometric Least Squares Mean Ratio (%)</param_type>
            <param_value>58.3</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>30.2</ci_lower_limit>
            <ci_upper_limit>113</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Informal BE assessment using the conventional BE limits of 80% to 125%.</non_inferiority_desc>
            <param_type>Geometric Least Squares Mean Ratio (%)</param_type>
            <param_value>21.2</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>13.6</ci_lower_limit>
            <ci_upper_limit>32.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 weeks</time_frame>
      <desc>Overall number of baseline participants used to determine number of participants at risk.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1: Mild Renal Impairment + RDEA3170 15 mg</title>
          <description>Mild Renal Impairment (eCrCl of 60 to &lt; 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted</description>
        </group>
        <group group_id="E2">
          <title>Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg</title>
          <description>Moderate Renal Impairment (eCrCl of 30 to &lt; 60 mL/min) + RDEA3170 15 mg qd fasted</description>
        </group>
        <group group_id="E3">
          <title>Cohort 3: Severe Renal Impairment + RDEA3170 15 mg</title>
          <description>Severe Renal Impairment (eCrCl of 15 to &lt; 30 mL/min) + RDEA3170 15 mg qd fasted</description>
        </group>
        <group group_id="E4">
          <title>Cohort 4: Normal Renal Function + RDEA3170 15 mg</title>
          <description>Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 15.1</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="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Vessel puncture site haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </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="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pseudofolliculitis barbae</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </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/NCT02219516
org study id: RDEA3170-108
nct id: NCT02219516
lead sponsor: 
has dmc: No
This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD)
      study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
description: Cmax following a single administration of RDEA3170 to subjects with various degrees of renal function
measure: Time of Occurrence of Maximum Observed Concentration (Tmax)
time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
description: Tmax following a single administration of RDEA3170 to subjects with various degrees of renal function
measure: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
description: AUC last following a single administration of RDEA3170 to subjects with various degrees of renal function
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞)
time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
description: AUC∞ following a single administration of RDEA3170 to subjects with various degrees of renal function
measure: Apparent Terminal Half-life (t1/2)
time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
description: t1/2 following a single administration of RDEA3170 to subjects with various degrees of renal function
measure: Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72)
time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
description: CLNR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function
measure: Total Body Clearance Corrected for Bioavailability (CL/F)
time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
description: CL/F following a single administration of RDEA3170 to subjects with various degrees of renal function
measure: Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72)
time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
description: CLR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function
measure: Incidence of Treatment-Emergent Adverse Events
time frame: 5 weeks
measure: Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine
time frame: Screening, Day -1 ( -24, -21, -18, -and -12 hours predose), and Day 1 (within 30 minutes prior to dosing and at 3, 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours postdose)
arm group label: Cohort 1: Mild renal impairment
arm group type: Experimental
description: RDEA3170 15 mg once daily fasted
arm group label: Cohort 2: Moderate renal impairment
arm group type: Experimental
description: RDEA3170 15 mg once daily fasted
arm group label: Cohort 3: Severe renal impairment
arm group type: Experimental
description: RDEA3170 15 mg once daily fasted
arm group label: Cohort 4: Control subjects with normal renal function
arm group type: Experimental
description: RDEA3170 15 mg once daily fasted
intervention type: Drug
intervention name: RDEA3170
arm group label: Cohort 1: Mild renal impairment
arm group label: Cohort 2: Moderate renal impairment
arm group label: Cohort 3: Severe renal impairment
arm group label: Cohort 4: Control subjects with normal renal function
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: J. Hall, MD
role: Study Director
affiliation: Ardea Biosciences, Inc.
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Verinurad
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 