<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/NCT03023826</url>
  </required_header>
  <id_info>
    <org_study_id>15567</org_study_id>
    <secondary_id>I7X-MC-LLCE</secondary_id>
    <nct_id>NCT03023826</nct_id>
  </id_info>
  <brief_title>A Study of LY3202626 in Healthy Participants</brief_title>
  <official_title>Relative Bioavailability and Food Effect Study in Healthy Subjects Administered Two Different Formulations of LY3202626</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>
      The purposes of this study are to determine:&#xD;
&#xD;
        -  If there are any differences in the way LY3202626 is handled by the body when taken in&#xD;
           two different forms&#xD;
&#xD;
        -  Whether a high fat meal affects the way the body handles LY3202626&#xD;
&#xD;
        -  How well tolerated LY3202626 is&#xD;
&#xD;
      There are three (3) study periods for all participants. Participants will be admitted to the&#xD;
      clinical research unit (CRU) each period and will be discharged from the CRU following the&#xD;
      completion of 2 overnight stays and up to 36 hours after dosing with LY3202626.&#xD;
&#xD;
      The study will last about 50 days, not including screening.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 15, 2017</start_date>
  <completion_date type="Actual">April 4, 2017</completion_date>
  <primary_completion_date type="Actual">April 4, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626</measure>
    <time_frame>Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose</time_frame>
    <description>Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626</measure>
    <time_frame>Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose</time_frame>
    <description>PK is the area under the concentration versus time curve from time zero to infinity (AUC[0-∞]) of LY3202626</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626</measure>
    <time_frame>Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose</time_frame>
    <description>PK is the AUC from time zero to time t, where t is the last time point with a measurable concentration (AUC[0-tlast]) of LY3202626</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>LY3202626 (R-Fasting)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of LY3202626 (R) capsule under fasting conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY3202626 (T1-Fasting)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of LY3202626 (T1) tablet under fasting conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY3202626 (T1-Fed)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of LY3202626 (T1) following a high fat breakfast.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3202626 (R-Fasting)</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>LY3202626 (R-Fasting)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3202626 (T1-Fasting)</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>LY3202626 (T1-Fasting)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3202626 (T1-Fed)</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>LY3202626 (T1-Fed)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are overtly healthy males or females, as determined by medical history and physical&#xD;
             examination&#xD;
&#xD;
          -  Female participants must be of non-childbearing potential confirmed by medical history&#xD;
             or menopause&#xD;
&#xD;
          -  Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²)&#xD;
             inclusive, at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are investigative site personnel directly affiliated with this study and their&#xD;
             immediate families&#xD;
&#xD;
          -  Are currently enrolled in a clinical trial involving an investigational product or any&#xD;
             other type of medical research judged not to be scientifically or medically compatible&#xD;
             with this study&#xD;
&#xD;
          -  Have participated, within the last 30 days, in a clinical trial involving an&#xD;
             investigational product. If the previous investigational product has a long half-life,&#xD;
             3 months or 5 half-lives (whichever is longer) should have passed&#xD;
&#xD;
          -  Have previously completed or withdrawn from this study or any other study&#xD;
             investigating LY3202626, and have previously received the investigational product&#xD;
&#xD;
          -  Have a history of or current cardiovascular, respiratory, hepatic, renal,&#xD;
             gastrointestinal, endocrine, hematological, or neurological disorders capable of&#xD;
             significantly altering the absorption, metabolism, or elimination of drugs; of&#xD;
             constituting a risk when taking the investigational product; or of interfering with&#xD;
             the interpretation of data&#xD;
&#xD;
          -  Have a history of head trauma with loss of consciousness within the last 5 years&#xD;
&#xD;
          -  Have known or ongoing psychiatric disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.</name>
      <address>
        <city>Singapore</city>
        <zip>117597</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <results_first_submitted>March 22, 2021</results_first_submitted>
  <results_first_submitted_qc>March 22, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 19, 2021</results_first_posted>
  <last_update_submitted>March 22, 2021</last_update_submitted>
  <last_update_submitted_qc>March 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 10, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT03023826/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT03023826/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants were randomized to 1 of 6 sequences in 3 periods.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Sequence (ACB)</title>
          <description>A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.&#xD;
B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.&#xD;
C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.</description>
        </group>
        <group group_id="P2">
          <title>Sequence (CAB)</title>
          <description>A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.&#xD;
B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.&#xD;
C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.</description>
        </group>
        <group group_id="P3">
          <title>Sequence (BAC)</title>
          <description>A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.&#xD;
B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.&#xD;
C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.</description>
        </group>
        <group group_id="P4">
          <title>Sequence (ABC)</title>
          <description>A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.&#xD;
B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.&#xD;
C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.</description>
        </group>
        <group group_id="P5">
          <title>Sequence (BCA)</title>
          <description>A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.&#xD;
B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.&#xD;
C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.</description>
        </group>
        <group group_id="P6">
          <title>Sequence (CBA)</title>
          <description>A: Reference (R): Single oral 12 milligram (mg) dose of LY3202626 capsule (R) under fasting conditions.&#xD;
B: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.&#xD;
C: Test (T1-12): Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast..</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least One Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="5"/>
              </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 group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="5"/>
              </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 group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 3</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="5"/>
              </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 group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants who received at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>Single oral 12 mg dose of LY3202626 capsule (R) under fasting conditions, LY3202626 tablet (T1) under fasting conditions and LY3202626 tablet (T1) following a high-fat meal.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="26"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.2" spread="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </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="26"/>
                  </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="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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>Count of Participants</param>
          <class_list>
            <class>
              <title>Singapore</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626</title>
        <description>Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626</description>
        <time_frame>Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose</time_frame>
        <population>All randomized participants who received at least one dose and who had evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>12 mg LY3202626 (R-Fasting)</title>
            <description>Single oral 12 mg dose of LY3202626 capsule (R) under fasting conditions.</description>
          </group>
          <group group_id="O2">
            <title>12 mg LY3202626 (T1-Fasting)</title>
            <description>Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.</description>
          </group>
          <group group_id="O3">
            <title>12 mg LY3202626 (T1-Fed)</title>
            <description>Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626</title>
          <description>Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626</description>
          <population>All randomized participants who received at least one dose and who had evaluable PK data.</population>
          <units>nanogram/milliliter (ng/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.9" spread="64"/>
                    <measurement group_id="O2" value="36.1" spread="45"/>
                    <measurement group_id="O3" value="39.4" spread="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626</title>
        <description>PK is the area under the concentration versus time curve from time zero to infinity (AUC[0-∞]) of LY3202626</description>
        <time_frame>Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>12 mg LY3202626 (R-Fasting)</title>
            <description>Single oral 12 mg dose of LY3202626 capsule (R) under fasting conditions.</description>
          </group>
          <group group_id="O2">
            <title>12 mg LY3202626 (T1-Fasting)</title>
            <description>Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.</description>
          </group>
          <group group_id="O3">
            <title>12 mg LY3202626 (T1-Fed)</title>
            <description>Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626</title>
          <description>PK is the area under the concentration versus time curve from time zero to infinity (AUC[0-∞]) of LY3202626</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable PK data.</population>
          <units>hour*nanogram/milliliter (h*ng/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="540" spread="62"/>
                    <measurement group_id="O2" value="707" spread="45"/>
                    <measurement group_id="O3" value="702" spread="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626</title>
        <description>PK is the AUC from time zero to time t, where t is the last time point with a measurable concentration (AUC[0-tlast]) of LY3202626</description>
        <time_frame>Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose</time_frame>
        <population>All randomized participants who received at least one dose of study drug and who had evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>12 mg LY3202626 (R-Fasting)</title>
            <description>Single oral 12 mg dose of LY3202626 capsule (R) under fasting conditions.</description>
          </group>
          <group group_id="O2">
            <title>12 mg LY3202626 (T1-Fasting)</title>
            <description>Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.</description>
          </group>
          <group group_id="O3">
            <title>12 mg LY3202626 (T1-Fed)</title>
            <description>Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626</title>
          <description>PK is the AUC from time zero to time t, where t is the last time point with a measurable concentration (AUC[0-tlast]) of LY3202626</description>
          <population>All randomized participants who received at least one dose of study drug and who had evaluable PK data.</population>
          <units>h*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="531" spread="62"/>
                    <measurement group_id="O2" value="667" spread="47"/>
                    <measurement group_id="O3" value="691" spread="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to End of Study (Up to 3 Months)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>12 mg LY3202626 (R-Fasting)</title>
          <description>Single oral 12 mg dose of LY3202626 capsule (R) under fasting conditions.</description>
        </group>
        <group group_id="E2">
          <title>12 mg LY3202626 (T1-Fasting)</title>
          <description>Single oral 12 mg dose of LY3202626 tablet (T1) under fasting conditions.</description>
        </group>
        <group group_id="E3">
          <title>12 mg LY3202626 (T1-Fed)</title>
          <description>Single oral 12 mg dose of LY3202626 tablet (T1) following a high fat breakfast.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1</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="8" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site bruise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Catheter site erythema</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Catheter site pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Catheter site swelling</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Vessel puncture site bruise</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </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>
      <email>ClinicalTrials.gov@lilly.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/NCT03023826
org study id: 15567
secondary id: I7X-MC-LLCE
nct id: NCT03023826
lead sponsor: 
has dmc: No
The purposes of this study are to determine:

        -  If there are any differences in the way LY3202626 is handled by the body when taken in
           two different forms

        -  Whether a high fat meal affects the way the body handles LY3202626

        -  How well tolerated LY3202626 is

      There are three (3) study periods for all participants. Participants will be admitted to the
      clinical research unit (CRU) each period and will be discharged from the CRU following the
      completion of 2 overnight stays and up to 36 hours after dosing with LY3202626.

      The study will last about 50 days, not including screening.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626
time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose
description: Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626
measure: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626
time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose
description: PK is the area under the concentration versus time curve from time zero to infinity (AUC[0-∞]) of LY3202626
measure: PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626
time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose
description: PK is the AUC from time zero to time t, where t is the last time point with a measurable concentration (AUC[0-tlast]) of LY3202626
arm group label: LY3202626 (R-Fasting)
arm group type: Experimental
description: Single oral dose of LY3202626 (R) capsule under fasting conditions.
arm group label: LY3202626 (T1-Fasting)
arm group type: Experimental
description: Single oral dose of LY3202626 (T1) tablet under fasting conditions.
arm group label: LY3202626 (T1-Fed)
arm group type: Experimental
description: Single oral dose of LY3202626 (T1) following a high fat breakfast.
intervention type: Drug
intervention name: LY3202626 (R-Fasting)
description: Administered orally
arm group label: LY3202626 (R-Fasting)
intervention type: Drug
intervention name: LY3202626 (T1-Fasting)
description: Administered orally
arm group label: LY3202626 (T1-Fasting)
intervention type: Drug
intervention name: LY3202626 (T1-Fed)
description: Administered orally
arm group label: LY3202626 (T1-Fed)
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
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: Singapore
responsible party type: Sponsor
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 