<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/NCT02242981</url>
  </required_header>
  <id_info>
    <org_study_id>15517</org_study_id>
    <secondary_id>I7T-MC-RMAA</secondary_id>
    <nct_id>NCT02242981</nct_id>
  </id_info>
  <brief_title>A Study of How the Body Breaks Down and Eliminates LY2623091</brief_title>
  <official_title>Disposition of [14C]-LY2623091 Following Oral Administration in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This type of study is called a radiolabeled study. For this study, LY2623091 (study drug) has&#xD;
      been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally&#xD;
      occurring radioactive form of the element, carbon. This study will increase understanding&#xD;
      about how the drug appears in the blood, urine, and stool after it is administered to healthy&#xD;
      participants. Information about any side effects that may occur will also be collected. This&#xD;
      study will last up to 22 days for each participant, not including screening. Screening is&#xD;
      required within 28 days prior to enrollment&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered</measure>
    <time_frame>Screening (urine only), Day -1, Day 1 (0 to 6, 6 to 12, and 12 to 24 hours), and at 24 hour intervals thereafter until the study release criteria have been met (up to 504 hours)</time_frame>
    <description>Cumulative percent of radioactive dose recovered in urine and feces after administration at specified intervals.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091</measure>
    <time_frame>Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2623091</measure>
    <time_frame>Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Pharmacokinetics: Maximum Concentration (Cmax) of LY2623091</measure>
    <time_frame>Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces</measure>
    <time_frame>Day 1 (predose, 2, 3, 4, 6, 8, and 12 hours postdose), and at 24 and 48 hours postdose</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>LY2623091</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of LY2623091</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY2623091</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>LY2623091</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overtly healthy males; as determined by physical examination, clinical laboratory&#xD;
             tests, medical history and electrocardiograms (ECGs).&#xD;
&#xD;
          -  With a body mass index of 18.5 to 32.0 kilogram per square meter (kg/m^2), inclusive.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <results_first_submitted>June 9, 2020</results_first_submitted>
  <results_first_submitted_qc>June 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 26, 2020</results_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>LY2623091</title>
          <description>Single dose of 25 milligrams (mg) LY2623091 containing carbon-14 [¹⁴C]-LY2623091 (approximately 100 microcuries [µCi]) administered orally.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants who received study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>LY2623091</title>
          <description>Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
          </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="40" spread="14.0"/>
                  </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_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered</title>
        <description>Cumulative percent of radioactive dose recovered in urine and feces after administration at specified intervals.</description>
        <time_frame>Screening (urine only), Day -1, Day 1 (0 to 6, 6 to 12, and 12 to 24 hours), and at 24 hour intervals thereafter until the study release criteria have been met (up to 504 hours)</time_frame>
        <population>All participants who received study drug and had quantifiable levels of radioactivity in urine and feces.</population>
        <group_list>
          <group group_id="O1">
            <title>LY2623091</title>
            <description>Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered</title>
          <description>Cumulative percent of radioactive dose recovered in urine and feces after administration at specified intervals.</description>
          <population>All participants who received study drug and had quantifiable levels of radioactivity in urine and feces.</population>
          <units>percentage of radioactive dose recovered</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Feces</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.5" spread="4.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.39" spread="0.454"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091</title>
        <time_frame>Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)</time_frame>
        <population>All participants who received study drug and had evaluable AUC(0-tlast) values.</population>
        <group_list>
          <group group_id="O1">
            <title>LY2623091</title>
            <description>Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091</title>
          <population>All participants who received study drug and had evaluable AUC(0-tlast) values.</population>
          <units>nanograms*hour/milliliter (ng*h/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11800" spread="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2623091</title>
        <time_frame>Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)</time_frame>
        <population>All participants who received study drug and had evaluable AUC(0-inf) values.</population>
        <group_list>
          <group group_id="O1">
            <title>LY2623091</title>
            <description>Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2623091</title>
          <population>All participants who received study drug and had evaluable AUC(0-inf) values.</population>
          <units>ng*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11800" spread="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Pharmacokinetics: Maximum Concentration (Cmax) of LY2623091</title>
        <time_frame>Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)</time_frame>
        <population>All participants who received study drug and had evaluable Cmax values.</population>
        <group_list>
          <group group_id="O1">
            <title>LY2623091</title>
            <description>Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Pharmacokinetics: Maximum Concentration (Cmax) of LY2623091</title>
          <population>All participants who received study drug and had evaluable Cmax values.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="482" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces</title>
        <time_frame>Day 1 (predose, 2, 3, 4, 6, 8, and 12 hours postdose), and at 24 and 48 hours postdose</time_frame>
        <population>All participants who received study drug and had evaluable plasma, urine, and fecal samples.</population>
        <group_list>
          <group group_id="O1">
            <title>LY2623091</title>
            <description>Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces</title>
          <population>All participants who received study drug and had evaluable plasma, urine, and fecal samples.</population>
          <units>metabolites</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Plasma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Urine was not profiled due to the low percentage of dose excreted in urine.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feces</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.</desc>
      <group_list>
        <group group_id="E1">
          <title>LY2623091</title>
          <description>Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally.</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="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 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="4" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Vessel puncture site bruise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Scratch</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="6"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
    </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/NCT02242981
org study id: 15517
secondary id: I7T-MC-RMAA
nct id: NCT02242981
lead sponsor: 
has dmc: No
This type of study is called a radiolabeled study. For this study, LY2623091 (study drug) has
      been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally
      occurring radioactive form of the element, carbon. This study will increase understanding
      about how the drug appears in the blood, urine, and stool after it is administered to healthy
      participants. Information about any side effects that may occur will also be collected. This
      study will last up to 22 days for each participant, not including screening. Screening is
      required within 28 days prior to enrollment
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
time frame: Screening (urine only), Day -1, Day 1 (0 to 6, 6 to 12, and 12 to 24 hours), and at 24 hour intervals thereafter until the study release criteria have been met (up to 504 hours)
description: Cumulative percent of radioactive dose recovered in urine and feces after administration at specified intervals.
measure: Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091
time frame: Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)
measure: Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2623091
time frame: Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)
measure: Plasma Pharmacokinetics: Maximum Concentration (Cmax) of LY2623091
time frame: Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)
measure: Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces
time frame: Day 1 (predose, 2, 3, 4, 6, 8, and 12 hours postdose), and at 24 and 48 hours postdose
arm group label: LY2623091
arm group type: Experimental
description: Single oral dose of LY2623091
intervention type: Drug
intervention name: LY2623091
description: Administered orally
arm group label: LY2623091
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 