<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/NCT02226653</url>
  </required_header>
  <id_info>
    <org_study_id>14627</org_study_id>
    <secondary_id>I1V-JE-EIAY</secondary_id>
    <nct_id>NCT02226653</nct_id>
  </id_info>
  <brief_title>A Study of Evacetrapib in Healthy Japanese Participants</brief_title>
  <official_title>A Bioequivalence and Food Effect Study of Evacetrapib Evaluating a Single Tablet Compared to Two Tablets in Healthy Japanese 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>
      The purpose of this study is to determine if two different dosing strategies for evacetrapib&#xD;
      will have essentially the same effect on the body. The study will also explore the effect of&#xD;
      a low fat meal on how the body absorbs evacetrapib. This study will last at least 15 weeks,&#xD;
      not including screening. Screening is required within 28 days prior to the date of first&#xD;
      dosing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (Fasted)</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK: Maximum Concentration (Cmax) of Evacetrapib (Fasted)</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib (Fasted and Fed)</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK: AUC(0-∞)of Evacetrapib (Fasted and Fed)</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK: Cmax of Evacetrapib (Fasted and Fed)</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Evacetrapib (reference)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of 1 tablet of evacetrapib on Day 1 of up to three of five periods</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Evacetrapib (test)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of 2 tablets of evacetrapib on Day 1 of up to three of five periods</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Evacetrapib</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Evacetrapib (reference)</arm_group_label>
    <arm_group_label>Evacetrapib (test)</arm_group_label>
    <other_name>LY2484595</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overtly healthy Japanese, as determined by medical history and physical examination&#xD;
&#xD;
          -  Have a body mass index (BMI) of 18.0 to 29.9 kg/m^2&#xD;
&#xD;
          -  Are reliable and willing to make themselves available for the duration of the study&#xD;
             and are willing to follow study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the&#xD;
             investigator, increases the risks associated with participating in the study&#xD;
&#xD;
          -  Have an abnormal supine blood pressure as determined by the investigator&#xD;
&#xD;
          -  Have a history or presence of 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 study medication; or of interfering with the&#xD;
             interpretation of data&#xD;
&#xD;
          -  Are women who are pregnant or lactating&#xD;
&#xD;
          -  Have used or intend to use over-the-counter, prescription medications, or herbal&#xD;
             medicine 14 days prior to enrollment and during the study&#xD;
&#xD;
          -  Have donated blood of more than 400 mL in the last 12 weeks (males) or in the last 16&#xD;
             weeks (females), or any blood donation (including apheresis) within the last 4 weeks&#xD;
&#xD;
          -  Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14&#xD;
             units per week (females), or are unwilling to abide by alcohol restrictions&#xD;
&#xD;
          -  Are participants who currently smoke more than 10 cigarettes per day or are unwilling&#xD;
             to abide by smoking restrictions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 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>Fukuoka</city>
        <zip>812-0025</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <results_first_submitted>February 18, 2018</results_first_submitted>
  <results_first_submitted_qc>February 18, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 10, 2018</results_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Evacetrapib</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Periods 1 to 4 participants are in the fasting state and Period 5 participants were fed a low fat meal. There were two fixed sequences for Test (T) and Reference (R) doses with each participant receiving 5 doses. There was a washout period of at least 21 days between doses.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Reference/Test/Reference/Test/Test</title>
          <description>Reference (R) dose is a single oral dose of one - 130 mg tablet of evacetrapib on Day 1 of Period 1 and Day 1 of Period 3. Test (T) dose is a single oral dose of Test two - 65 mg tablets of evacetrapib on Day 1 of Period 2, Day 1 of Period 4 and Day 1 of Period 5. There was a washout period of at least 21 days between doses.</description>
        </group>
        <group group_id="P2">
          <title>Test/Reference/Test/Reference/Reference</title>
          <description>Test (T) dose is a single oral dose of two - 65 milligram (mg) tablets of evacetrapib on Day 1 of Period 1 and Day 1 of Period 3. Reference (R) is a single oral dose of Reference (R) one - 130 mg tablet of evacetrapib on Day 1 of Period 2, Day 1 of Period 4 and Day 1 of Period 5. There was a washout period of at least 21 days between doses.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period 1 Fasted State</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout Period 1 (at Least 21 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Treatment Period 2 Fasted State</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Washout Period 2 (at Least 21 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Treatment Period 3 Fasted State</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout Period 3 (at Least 21 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Treatment Period 4 Fasted State</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout Period 4 (at Least 21 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Treatment Period 5 Fed State</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Washout Period 5 (at Least 21 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Reference/Test/Reference/Test/Test</title>
          <description>Reference(R) dose is a single oral dose of Reference 1 one- 130 mg tablet of evacetrapib on Day 1 of Period 1 and Day 1 of Period 3. Then, Test (T) dose is a single oral dose of Test 2 two- 65 mg tablets of evacetrapib on Day 1 of Period 2, Day 1 of Period 4 and Day 1 of Period 5. There was a washout period of at least 21 days between doses.</description>
        </group>
        <group group_id="B2">
          <title>Test/Reference/Test/Reference/Reference</title>
          <description>Test (T) dose is a single oral dose of Test 2 two- 65 mg tablets of evacetrapib on Day 1 of Period 1 and Day 1 of Period 3. Then, Reference (R) dose is a single oral dose of Reference 1 one- 130 mg tablet of evacetrapib on Day 1 of Period 2, Day 1 of Period 4 and Day 1 of Period 5. There was a washout period of at least 21 days between doses.</description>
        </group>
        <group group_id="B3">
          <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="24"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="48"/>
          </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="33.2" spread="9.9"/>
                    <measurement group_id="B2" value="34.7" spread="11.3"/>
                    <measurement group_id="B3" value="33.9" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="36"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (Fasted)</title>
        <time_frame>Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4</time_frame>
        <population>All randomized participants who completed and had evaluable AUC(0-∞) bioequivalence fasted state data for Periods 1,2,3 and 4.</population>
        <group_list>
          <group group_id="O1">
            <title>Reference (Fasted)</title>
            <description>Reference dose is a single oral dose of Reference one- 130mg tablets of evacetrapib in fasted state in Period 1, 2, 3 and 4.</description>
          </group>
          <group group_id="O2">
            <title>Test (Fasted)</title>
            <description>Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 1, 2, 3 and 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (Fasted)</title>
          <population>All randomized participants who completed and had evaluable AUC(0-∞) bioequivalence fasted state data for Periods 1,2,3 and 4.</population>
          <units>nanogram·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="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14600" spread="40"/>
                    <measurement group_id="O2" value="14600" spread="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PK: Maximum Concentration (Cmax) of Evacetrapib (Fasted)</title>
        <time_frame>Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4</time_frame>
        <population>All randomized participants who completed and had evaluable Cmax bioequivalence fasted state data for Periods 1,2,3 and 4.</population>
        <group_list>
          <group group_id="O1">
            <title>Reference (Fasted)</title>
            <description>Reference dose is a single oral dose of Reference one- 130mg tablets of evacetrapib in fasted state in Period 1, 2, 3 and 4.</description>
          </group>
          <group group_id="O2">
            <title>Test (Fasted)</title>
            <description>Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 1, 2, 3 and 4.</description>
          </group>
        </group_list>
        <measure>
          <title>PK: Maximum Concentration (Cmax) of Evacetrapib (Fasted)</title>
          <population>All randomized participants who completed and had evaluable Cmax bioequivalence fasted state data for Periods 1,2,3 and 4.</population>
          <units>nanogram/milliliter (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="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1130" spread="53"/>
                    <measurement group_id="O2" value="1100" spread="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib (Fasted and Fed)</title>
        <time_frame>Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5</time_frame>
        <population>All randomized participants who completed and had evaluable Tmax Fasted and Fed State data for Periods 2, 4, and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Reference (Fasted)</title>
            <description>Reference dose is a single oral dose of Reference one- 130mg tablets of evacetrapib in fasted state in Periods 2 and 4.</description>
          </group>
          <group group_id="O2">
            <title>Reference (Fed)</title>
            <description>Reference dose is a single oral dose of Reference one- 130mg tablets of evacetrapib in fed state in Period 5.</description>
          </group>
          <group group_id="O3">
            <title>Test (Fasted)</title>
            <description>Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 2 and 4.</description>
          </group>
          <group group_id="O4">
            <title>Test (Fed)</title>
            <description>Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fed state in Period 5.</description>
          </group>
        </group_list>
        <measure>
          <title>PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib (Fasted and Fed)</title>
          <population>All randomized participants who completed and had evaluable Tmax Fasted and Fed State data for Periods 2, 4, and 5.</population>
          <units>hour (h)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.75" lower_limit="1.75" upper_limit="5.00"/>
                    <measurement group_id="O2" value="2.50" lower_limit="1.50" upper_limit="5.50"/>
                    <measurement group_id="O3" value="3.50" lower_limit="2.25" upper_limit="5.00"/>
                    <measurement group_id="O4" value="2.75" lower_limit="2.00" upper_limit="6.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK: AUC(0-∞)of Evacetrapib (Fasted and Fed)</title>
        <time_frame>Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5</time_frame>
        <population>All randomized participants who completed and had evaluable AUC(0-∞) Fasted and Fed State data for Periods 2,4, and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Reference (Fasted)</title>
            <description>Reference dose is a single oral dose of Reference one- 130mg tablets of evacetrapib in fasted state in Periods 2 and 4.</description>
          </group>
          <group group_id="O2">
            <title>Reference (Fed)</title>
            <description>Reference dose is a single oral dose of Reference one- 130mg tablets of evacetrapib in fed state in Periods 5.</description>
          </group>
          <group group_id="O3">
            <title>Test (Fasted)</title>
            <description>Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 2 and 4.</description>
          </group>
          <group group_id="O4">
            <title>Test (Fed)</title>
            <description>Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fed state in Period 5.</description>
          </group>
        </group_list>
        <measure>
          <title>PK: AUC(0-∞)of Evacetrapib (Fasted and Fed)</title>
          <population>All randomized participants who completed and had evaluable AUC(0-∞) Fasted and Fed State data for Periods 2,4, and 5.</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="23"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14800" spread="39"/>
                    <measurement group_id="O2" value="18900" spread="24"/>
                    <measurement group_id="O3" value="14600" spread="39"/>
                    <measurement group_id="O4" value="18600" spread="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK: Cmax of Evacetrapib (Fasted and Fed)</title>
        <time_frame>Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5</time_frame>
        <population>All randomized participants who completed and had evaluable Cmax Fasted and Fed State data for Periods 2,4, and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Reference (Fasted)</title>
            <description>Reference dose is a single oral dose of Reference one- 130mg tablets of evacetrapib in fasted state in Periods 2 and 4.</description>
          </group>
          <group group_id="O2">
            <title>Reference (Fed)</title>
            <description>Reference dose is a single oral dose of Reference one- 130mg tablets of evacetrapib in fed state in Period 5.</description>
          </group>
          <group group_id="O3">
            <title>Test (Fasted)</title>
            <description>Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 2 and 4.</description>
          </group>
          <group group_id="O4">
            <title>Test (Fed)</title>
            <description>Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fed state in Period 5.</description>
          </group>
        </group_list>
        <measure>
          <title>PK: Cmax of Evacetrapib (Fasted and Fed)</title>
          <population>All randomized participants who completed and had evaluable Cmax Fasted and Fed State data for Periods 2,4, and 5.</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="23"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1100" spread="57"/>
                    <measurement group_id="O2" value="1450" spread="21"/>
                    <measurement group_id="O3" value="1090" spread="44"/>
                    <measurement group_id="O4" value="1480" spread="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>The safety population includes all 48 participants who enrolled in the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>130 mg Tablet Evacetrapib (Fasted)</title>
          <description>Reference dose is a single oral dose of Reference one- 130 mg tablets of evacetrapib in fasted state in Periods 1, 2, 3, and 4.</description>
        </group>
        <group group_id="E2">
          <title>2 x 65 mg Tablets Evacetrapib (Fasted)</title>
          <description>Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 1, 2, 3, and 4.</description>
        </group>
        <group group_id="E3">
          <title>130 mg Tablet Evacetrapib (Fed)</title>
          <description>Reference dose is a single oral dose of Reference one- 130 mg tablets of in fed state in Period 5.</description>
        </group>
        <group group_id="E4">
          <title>2 x 65 mg Tablets Evacetrapib (Fed)</title>
          <description>Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fed state in Period 5.</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="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </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="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Neutrophil count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </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/NCT02226653
org study id: 14627
secondary id: I1V-JE-EIAY
nct id: NCT02226653
lead sponsor: 
has dmc: No
The purpose of this study is to determine if two different dosing strategies for evacetrapib
      will have essentially the same effect on the body. The study will also explore the effect of
      a low fat meal on how the body absorbs evacetrapib. This study will last at least 15 weeks,
      not including screening. Screening is required within 28 days prior to the date of first
      dosing.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (Fasted)
time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4
measure: PK: Maximum Concentration (Cmax) of Evacetrapib (Fasted)
time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4
measure: PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib (Fasted and Fed)
time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5
measure: PK: AUC(0-∞)of Evacetrapib (Fasted and Fed)
time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5
measure: PK: Cmax of Evacetrapib (Fasted and Fed)
time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5
arm group label: Evacetrapib (reference)
arm group type: Experimental
description: Single oral dose of 1 tablet of evacetrapib on Day 1 of up to three of five periods
arm group label: Evacetrapib (test)
arm group type: Experimental
description: Single oral dose of 2 tablets of evacetrapib on Day 1 of up to three of five periods
intervention type: Drug
intervention name: Evacetrapib
description: Administered orally
arm group label: Evacetrapib (reference)
arm group label: Evacetrapib (test)
other name: LY2484595
criteria: 
gender: All
minimum age: 20 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: Japan
responsible party type: Sponsor
mesh term: Evacetrapib
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 