<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/NCT02989389</url>
  </required_header>
  <id_info>
    <org_study_id>16610</org_study_id>
    <secondary_id>I9F-MC-SCAA</secondary_id>
    <nct_id>NCT02989389</nct_id>
  </id_info>
  <brief_title>A Study of LY3323795 in Healthy Participants</brief_title>
  <official_title>Single-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3323795 in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to investigate the safety of LY3323795 and the effects it&#xD;
      has on the body. The study drug or placebo (sugar pill) will be given by mouth to healthy&#xD;
      participants. The study has three parts. Each participant may only enroll in one part. The&#xD;
      study will last 14 to 43 days, depending on the part. Screening must be completed prior to&#xD;
      study start.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2016</start_date>
  <completion_date type="Actual">July 21, 2017</completion_date>
  <primary_completion_date type="Actual">July 21, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration</measure>
    <time_frame>Baseline to Study Completion (up to Day 43)</time_frame>
    <description>Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 19.1. A summary of non-serious adverse events and all serious adverse events, regardless of causality is located in the Reported Adverse Events section.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3323795 in Plasma</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72,96,120,144 hours, post dose</time_frame>
    <description>Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3323795 in plasma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3323795 in Cerebrospinal Fluid (CSF)</measure>
    <time_frame>-4, -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36 hours, post dose</time_frame>
    <description>Part B Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3323795 in cerebrospinal fluid (CSF).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3323795 in Plasma</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72,96,120,144 hours, post dose</time_frame>
    <description>Pharmacokinetics (PK): Area under the concentration time curve from time zero to tlast (AUC[0-tlast]) of LY3323795 in plasma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3323795 in Cerebrospinal Fluid (CSF)</measure>
    <time_frame>-4, -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36 hours, post dose</time_frame>
    <description>Part B Pharmacokinetics (PK): Area under the concentration time curve from time zero to tlast (AUC[0-tlast]) of LY3323795 in cerebrospinal fluid (CSF).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics (PD): Change From Baseline in Plasma Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂</measure>
    <time_frame>Baseline through 144 hours</time_frame>
    <description>Amyloid beta is a peptide fragment of the amyloid precursor protein, plasma concentrations of Aβ1-40 and Aβ1-42 were determined using validated immunoassay methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B Pharmacodynamics (PD): Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂</measure>
    <time_frame>Baseline through 36 hours</time_frame>
    <description>Amyloid beta is a peptide fragment of the amyloid precursor protein, CSF concentrations of Aβ1-40, Aβ1-42 were determined using validated immunoassay methods.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>LY3323795 (Part A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received escalating doses of 0.3 mg (milligrams), 1 mg, 3 mg, 10 mg, 30 mg and 100 mg of LY3323795 orally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Part A)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received placebo identical to LY3323795 orally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY3323795 (Part B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 6 mg, 20 mg and 80 mg of LY3323795 orally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Part B)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received placebo identical to LY3323795 orally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY3323795 (Part C)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part C was not initiated due to a Lilly internal strategy decision.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY3323795 + Itraconazole (Part C)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part C was not initiated due to a Lilly internal strategy decision.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3323795</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>LY3323795 (Part A)</arm_group_label>
    <arm_group_label>LY3323795 (Part B)</arm_group_label>
    <arm_group_label>LY3323795 (Part C)</arm_group_label>
    <arm_group_label>LY3323795 + Itraconazole (Part C)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Itraconazole</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>LY3323795 + Itraconazole (Part C)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Placebo (Part A)</arm_group_label>
    <arm_group_label>Placebo (Part B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males or females of non-childbearing potential at time of screening&#xD;
&#xD;
          -  Have a body mass index (BMI) between 18.0 kilograms per square meter (kg/m²) and 32.0&#xD;
             kg/m², inclusive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have participated, within the last 30 days, in a clinical trial involving an&#xD;
             investigational product.&#xD;
&#xD;
          -  Have a QT corrected for heart rate (QTc) (using Bazett's formula) interval value of&#xD;
             greater than 450 millisecond (msec) (males) or greater than 470 msec (females)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 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>California Clinical Trials Medical Group</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <results_first_submitted>March 9, 2020</results_first_submitted>
  <results_first_submitted_qc>April 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 20, 2020</results_first_posted>
  <last_update_submitted>April 9, 2020</last_update_submitted>
  <last_update_submitted_qc>April 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2020</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>Itraconazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>December 2, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT02989389/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>December 20, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT02989389/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Part A was a dose-escalation 3-period crossover with 2 alternating cohorts (Cohorts 1 and 2). There was 14 days of washout time between each dose. Part B was a single-dose, 3-cohort (Cohorts 3, 4 and 5) study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part A-Cohort 1 (Sequence 1)</title>
          <description>Participants received 0.3 milligrams (mg), 3 mg, 30 mg LY3323795 and Placebo. Period 1: Placebo, Period 2: 3 mg LY3323795, Period 3: 30 mg LY3323795</description>
        </group>
        <group group_id="P2">
          <title>Part A-Cohort 1 (Sequence 2)</title>
          <description>Participants received 0.3 mg, 3 mg, 30 mg LY3323795 and Placebo. Period 1: 0.3 mg LY3323795, Period 2: Placebo, Period 3: 30 mg LY3323795</description>
        </group>
        <group group_id="P3">
          <title>Part A-Cohort 1 (Sequence 3)</title>
          <description>Participants received 0.3 mg, 3 mg, 30 mg LY3323795 and Placebo. Period 1: 0.3 mg LY3323795, Period 2: 3 mg LY3323795, Period 3: Placebo</description>
        </group>
        <group group_id="P4">
          <title>Part A-Cohort 2 (Sequence 1)</title>
          <description>Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: 1 mg LY3323795, Period 2: 10 mg LY3323795, Period 3: Placebo</description>
        </group>
        <group group_id="P5">
          <title>Part A-Cohort 2 (Sequence 2)</title>
          <description>Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: Placebo, Period 2: 10 mg LY3323795, Period 3: 100 mg LY3323795</description>
        </group>
        <group group_id="P6">
          <title>Part A-Cohort 2 (Sequence 3)</title>
          <description>Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: 1 mg LY3323795, Period 2: Placebo, Period 3: 100 mg LY3323795</description>
        </group>
        <group group_id="P7">
          <title>Part B, 6 mg LY3323795</title>
          <description>Participants received 6 mg of LY3323795 orally.</description>
        </group>
        <group group_id="P8">
          <title>Part B, 20 mg LY3323795</title>
          <description>Participants received 20 mg of LY3323795 orally.</description>
        </group>
        <group group_id="P9">
          <title>Part B, 80 mg LY3323795</title>
          <description>Participants received 80 mg of LY3323795 orally.</description>
        </group>
        <group group_id="P10">
          <title>Part B, Placebo</title>
          <description>Participants received placebo identical to LY3323795 orally.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="5"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="5"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="5"/>
                <participants group_id="P9" count="5"/>
                <participants group_id="P10" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <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 group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" 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="0"/>
                <participants group_id="P2" count="1"/>
                <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 group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</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 group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" 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="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="0">Part B was planned as a single period study.</participants>
                <participants group_id="P8" count="0">Part B was planned as a single period study.</participants>
                <participants group_id="P9" count="0">Part B was planned as a single period study.</participants>
                <participants group_id="P10" count="0">Part B was planned as a single period study.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </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 group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" 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="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </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 group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants who received at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Part A-Cohort 1 (Sequence 1)</title>
          <description>Participants received 0.3 milligrams (mg), 3 mg, 30 mg LY3323795 and Placebo. Period 1: Placebo, Period 2: 3 mg LY3323795, Period 3: 30 mg LY3323795.</description>
        </group>
        <group group_id="B2">
          <title>Part A-Cohort 1 (Sequence 2)</title>
          <description>Participants received 0.3 mg, 3 mg, 30 mg LY3323795 and Placebo. Period 1: 0.3 mg LY3323795, Period 2: Placebo, Period 3: 30 mg LY3323795.</description>
        </group>
        <group group_id="B3">
          <title>Part A-Cohort 1 (Sequence 3)</title>
          <description>Participants received 0.3 mg, 3 mg, 30 mg LY3323795 and Placebo. Period 1: 0.3 mg LY3323795, Period 2: 3 mg LY3323795, Period 3: Placebo.</description>
        </group>
        <group group_id="B4">
          <title>Part A-Cohort 2 (Sequence 1)</title>
          <description>Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: 1 mg LY3323795, Period 2: 10 mg LY3323795, Period 3: Placebo.</description>
        </group>
        <group group_id="B5">
          <title>Part A-Cohort 2 (Sequence 2)</title>
          <description>Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: Placebo, Period 2: 10 mg LY3323795, Period 3: 100 mg LY3323795.</description>
        </group>
        <group group_id="B6">
          <title>Part A-Cohort 2 (Sequence 3)</title>
          <description>Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: 1 mg LY3323795, Period 2: Placebo, Period 3: 100 mg LY3323795.</description>
        </group>
        <group group_id="B7">
          <title>Part B, 6 mg LY3323795</title>
          <description>Participants received 6 mg of LY3323795 orally.</description>
        </group>
        <group group_id="B8">
          <title>Part B, 20 mg LY3323795</title>
          <description>Participants received 20 mg of LY3323795 orally.</description>
        </group>
        <group group_id="B9">
          <title>Part B, 80 mg LY3323795</title>
          <description>Participants received 80 mg of LY3323795 orally.</description>
        </group>
        <group group_id="B10">
          <title>Part B, Placebo</title>
          <description>Participants received placebo identical to LY3323795 orally.</description>
        </group>
        <group group_id="B11">
          <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="3"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="3"/>
            <count group_id="B4" value="3"/>
            <count group_id="B5" value="3"/>
            <count group_id="B6" value="3"/>
            <count group_id="B7" value="6"/>
            <count group_id="B8" value="5"/>
            <count group_id="B9" value="6"/>
            <count group_id="B10" value="6"/>
            <count group_id="B11" value="42"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="6"/>
                    <measurement group_id="B11" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="3"/>
                    <measurement group_id="B9" value="5"/>
                    <measurement group_id="B10" value="4"/>
                    <measurement group_id="B11" value="31"/>
                  </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="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="5"/>
                    <measurement group_id="B11" value="32"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="1"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="3"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" 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="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="3"/>
                    <measurement group_id="B9" value="3"/>
                    <measurement group_id="B10" value="3"/>
                    <measurement group_id="B11" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="3"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" 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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="6"/>
                    <measurement group_id="B11" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration</title>
        <description>Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 19.1. A summary of non-serious adverse events and all serious adverse events, regardless of causality is located in the Reported Adverse Events section.</description>
        <time_frame>Baseline to Study Completion (up to Day 43)</time_frame>
        <population>All randomized participants who received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A, Cohort 1, Placebo</title>
            <description>Participants received placebo identical to LY3323795 orally.</description>
          </group>
          <group group_id="O2">
            <title>Part A, Cohort 1, 0.3 mg LY3323795</title>
            <description>Participants received 0.3 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O3">
            <title>Part A, Cohort 1, 3 mg LY3323795</title>
            <description>Participants received 3 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O4">
            <title>Part A, Cohort 1, 30 mg LY3323795</title>
            <description>Participants received 30 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O5">
            <title>Part A, Cohort 2, Placebo</title>
            <description>Participants received placebo identical to LY3323795 orally.</description>
          </group>
          <group group_id="O6">
            <title>Part A, Cohort 2, 1 mg LY3323795</title>
            <description>Participants received 1 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O7">
            <title>Part A, Cohort 2, 10 mg LY3323795</title>
            <description>Participants received 10 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O8">
            <title>Part A, Cohort 2, 100 mg LY3323795</title>
            <description>Participants received 100 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O9">
            <title>Part B, Placebo</title>
            <description>Participants received placebo identical to LY3323795 orally.</description>
          </group>
          <group group_id="O10">
            <title>Part B, 6 mg LY3323795</title>
            <description>Participants received 6 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O11">
            <title>Part B, 20 mg LY3323795</title>
            <description>Participants received 20 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O12">
            <title>Part B, 80 mg LY3323795</title>
            <description>Participants received 80 mg of LY3323795 orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration</title>
          <description>Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 19.1. A summary of non-serious adverse events and all serious adverse events, regardless of causality is located in the Reported Adverse Events section.</description>
          <population>All randomized participants who received study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="5"/>
                <count group_id="O12" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3323795 in Plasma</title>
        <description>Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3323795 in plasma.</description>
        <time_frame>0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72,96,120,144 hours, post dose</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug and had evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A, Cohort 1, 0.3 mg LY3323795</title>
            <description>Participants received 0.3 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O2">
            <title>Part A, Cohort 2, 1 mg LY3323795</title>
            <description>Participants received 1 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O3">
            <title>Part A, Cohort 1, 3 mg LY3323795</title>
            <description>Participants received 3 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O4">
            <title>Part A, Cohort 2, 10 mg LY3323795</title>
            <description>Participants received 10 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O5">
            <title>Part A, Cohort 1, 30 mg LY3323795</title>
            <description>Participants received 30 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O6">
            <title>Part A, Cohort 2, 100 mg LY3323795</title>
            <description>Participants received 100 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O7">
            <title>Part B, 6 mg LY3323795</title>
            <description>Participants received 6 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O8">
            <title>Part B, 20 mg LY3323795</title>
            <description>Participants received 20 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O9">
            <title>Part B, 80 mg LY3323795</title>
            <description>Participants received 80 mg of LY3323795 orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3323795 in Plasma</title>
          <description>Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3323795 in plasma.</description>
          <population>All randomized participants who received at least 1 dose of study drug and had evaluable PK data.</population>
          <units>nanogram per 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="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.503" spread="32"/>
                    <measurement group_id="O2" value="1.77" spread="29"/>
                    <measurement group_id="O3" value="4.79" spread="24"/>
                    <measurement group_id="O4" value="15.7" spread="25"/>
                    <measurement group_id="O5" value="34.6" spread="35"/>
                    <measurement group_id="O6" value="89.1" spread="44"/>
                    <measurement group_id="O7" value="10.4" spread="45"/>
                    <measurement group_id="O8" value="27.2" spread="26"/>
                    <measurement group_id="O9" value="88.1" spread="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3323795 in Cerebrospinal Fluid (CSF)</title>
        <description>Part B Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3323795 in cerebrospinal fluid (CSF).</description>
        <time_frame>-4, -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36 hours, post dose</time_frame>
        <population>All randomized participants from Part B group, who received at least 1 dose of study drug and had evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B, 6 mg LY3323795</title>
            <description>Participants received 6 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O2">
            <title>Part B, 20 mg LY3323795</title>
            <description>Participants received 20 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O3">
            <title>Part B, 80 mg LY3323795</title>
            <description>Participants received 80 mg of LY3323795 orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3323795 in Cerebrospinal Fluid (CSF)</title>
          <description>Part B Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3323795 in cerebrospinal fluid (CSF).</description>
          <population>All randomized participants from Part B group, who received at least 1 dose of study drug and had evaluable PK data.</population>
          <units>nanogram per 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="6"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.293" spread="31"/>
                    <measurement group_id="O2" value="0.788" spread="11"/>
                    <measurement group_id="O3" value="2.86" spread="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3323795 in Plasma</title>
        <description>Pharmacokinetics (PK): Area under the concentration time curve from time zero to tlast (AUC[0-tlast]) of LY3323795 in plasma.</description>
        <time_frame>0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72,96,120,144 hours, post dose</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug and had evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A, Cohort 1, 0.3 mg LY3323795</title>
            <description>Participants received 0.3 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O2">
            <title>Part A, Cohort 2, 1 mg LY3323795</title>
            <description>Participants received 1 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O3">
            <title>Part A, Cohort 1, 3 mg LY3323795</title>
            <description>Participants received 3 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O4">
            <title>Part A, Cohort 2, 10 mg LY3323795</title>
            <description>Participants received 10 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O5">
            <title>Part A, Cohort 1, 30 mg LY3323795</title>
            <description>Participants received 10 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O6">
            <title>Part A, Cohort 2, 100 mg LY3323795</title>
            <description>Participants received 100 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O7">
            <title>Part B, 6 mg LY3323795</title>
            <description>Participants received 6 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O8">
            <title>Part B, 20 mg LY3323795</title>
            <description>Participants received 20 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O9">
            <title>Part B, 80 mg LY3323795</title>
            <description>Participants received 80 mg of LY3323795 orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3323795 in Plasma</title>
          <description>Pharmacokinetics (PK): Area under the concentration time curve from time zero to tlast (AUC[0-tlast]) of LY3323795 in plasma.</description>
          <population>All randomized participants who received at least 1 dose of study drug and had evaluable PK data.</population>
          <units>nanogram*hour per milliliter (ng*h/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="7"/>
                <count group_id="O9" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.67" spread="69"/>
                    <measurement group_id="O2" value="25.2" spread="28"/>
                    <measurement group_id="O3" value="73.4" spread="31"/>
                    <measurement group_id="O4" value="274" spread="14"/>
                    <measurement group_id="O5" value="663" spread="35"/>
                    <measurement group_id="O6" value="2370" spread="29"/>
                    <measurement group_id="O7" value="156" spread="17"/>
                    <measurement group_id="O8" value="441" spread="24"/>
                    <measurement group_id="O9" value="1950" spread="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3323795 in Cerebrospinal Fluid (CSF)</title>
        <description>Part B Pharmacokinetics (PK): Area under the concentration time curve from time zero to tlast (AUC[0-tlast]) of LY3323795 in cerebrospinal fluid (CSF).</description>
        <time_frame>-4, -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36 hours, post dose</time_frame>
        <population>All randomized participants from Part B group, who received at least 1 dose of study drug and had evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B, 6 mg LY3323795</title>
            <description>Participants received 6 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O2">
            <title>Part B, 20 mg LY3323795</title>
            <description>Participants received 20 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O3">
            <title>Part B, 80 mg LY3323795</title>
            <description>Participants received 80 mg of LY3323795 orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3323795 in Cerebrospinal Fluid (CSF)</title>
          <description>Part B Pharmacokinetics (PK): Area under the concentration time curve from time zero to tlast (AUC[0-tlast]) of LY3323795 in cerebrospinal fluid (CSF).</description>
          <population>All randomized participants from Part B group, who received at least 1 dose of study drug and had evaluable PK data.</population>
          <units>ng*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.46" spread="24"/>
                    <measurement group_id="O2" value="13.7" spread="16"/>
                    <measurement group_id="O3" value="55.1" spread="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacodynamics (PD): Change From Baseline in Plasma Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂</title>
        <description>Amyloid beta is a peptide fragment of the amyloid precursor protein, plasma concentrations of Aβ1-40 and Aβ1-42 were determined using validated immunoassay methods.</description>
        <time_frame>Baseline through 144 hours</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug and have baseline and at least one post-baseline plasma Aβ1-40 or Aβ1-42 data.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A, Cohort 1, 0.3 mg LY3323795</title>
            <description>Participants received 0.3 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O2">
            <title>Part A, Cohort 2, 1 mg LY3323795</title>
            <description>Participants received 1 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O3">
            <title>Part A, Cohort 1, 3 mg LY3323795</title>
            <description>Participants received 3 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O4">
            <title>Part A, Cohort 2, 10 mg LY3323795</title>
            <description>Participants received 10 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O5">
            <title>Part A, Cohort 1, 30 mg LY3323795</title>
            <description>Participants received 30 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O6">
            <title>Part A, Cohort 2, 100 mg LY3323795</title>
            <description>Participants received 100 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O7">
            <title>Part B, 6 mg LY3323795</title>
            <description>Participants received 6 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O8">
            <title>Part B, 20 mg LY3323795</title>
            <description>Participants received 20 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O9">
            <title>Part B, 80 mg LY3323795</title>
            <description>Participants received 80 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O10">
            <title>Placebo</title>
            <description>Participants received placebo identical to LY3323795 orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacodynamics (PD): Change From Baseline in Plasma Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂</title>
          <description>Amyloid beta is a peptide fragment of the amyloid precursor protein, plasma concentrations of Aβ1-40 and Aβ1-42 were determined using validated immunoassay methods.</description>
          <population>All randomized participants who received at least 1 dose of study drug and have baseline and at least one post-baseline plasma Aβ1-40 or Aβ1-42 data.</population>
          <units>Picogram per milliliter (pg/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="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="5"/>
                <count group_id="O10" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Aβ1-40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-39" spread="8"/>
                    <measurement group_id="O2" value="-52" spread="6"/>
                    <measurement group_id="O3" value="-71" spread="7"/>
                    <measurement group_id="O4" value="-76" spread="4"/>
                    <measurement group_id="O5" value="-76" spread="18"/>
                    <measurement group_id="O6" value="-89" spread="2"/>
                    <measurement group_id="O7" value="-79" spread="7"/>
                    <measurement group_id="O8" value="-81" spread="5"/>
                    <measurement group_id="O9" value="-89" spread="1"/>
                    <measurement group_id="O10" value="-23" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aβ1-42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22" spread="7"/>
                    <measurement group_id="O2" value="-33" spread="6"/>
                    <measurement group_id="O3" value="-49" spread="5"/>
                    <measurement group_id="O4" value="-60" spread="5"/>
                    <measurement group_id="O5" value="-63" spread="8"/>
                    <measurement group_id="O6" value="-75" spread="3"/>
                    <measurement group_id="O7" value="-54" spread="11"/>
                    <measurement group_id="O8" value="-58" spread="6"/>
                    <measurement group_id="O9" value="-64" spread="9"/>
                    <measurement group_id="O10" value="-12" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B Pharmacodynamics (PD): Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂</title>
        <description>Amyloid beta is a peptide fragment of the amyloid precursor protein, CSF concentrations of Aβ1-40, Aβ1-42 were determined using validated immunoassay methods.</description>
        <time_frame>Baseline through 36 hours</time_frame>
        <population>All randomized participants from Part B group, who received at least 1 dose of study drug and have baseline and at least one post-baseline CSF Aβ1-40 or Aβ1-42 data.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B, 6 mg LY3323795</title>
            <description>Participants received 6 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O2">
            <title>Part B, 20 mg LY3323795</title>
            <description>Participants received 20 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O3">
            <title>Part B, 80 mg LY3323795</title>
            <description>Participants received 80 mg of LY3323795 orally.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants received placebo identical to LY3323795 orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B Pharmacodynamics (PD): Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂</title>
          <description>Amyloid beta is a peptide fragment of the amyloid precursor protein, CSF concentrations of Aβ1-40, Aβ1-42 were determined using validated immunoassay methods.</description>
          <population>All randomized participants from Part B group, who received at least 1 dose of study drug and have baseline and at least one post-baseline CSF Aβ1-40 or Aβ1-42 data.</population>
          <units>Picogram per milliliter (pg/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="6"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Aβ 1-40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-51" spread="21"/>
                    <measurement group_id="O2" value="-69" spread="6"/>
                    <measurement group_id="O3" value="-88" spread="4"/>
                    <measurement group_id="O4" value="-12" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aβ 1-42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-37" spread="23"/>
                    <measurement group_id="O2" value="-71" spread="10"/>
                    <measurement group_id="O3" value="-81" spread="7"/>
                    <measurement group_id="O4" value="-17" spread="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Aβ 1-40</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.215</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-11.57</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-29.52</ci_lower_limit>
            <ci_upper_limit>10.96</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Aβ 1-40</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-60.53</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-69.79</ci_lower_limit>
            <ci_upper_limit>-48.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Aβ 1-40</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-87.07</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-90.21</ci_lower_limit>
            <ci_upper_limit>-82.92</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Aβ 1-42</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.015</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-19.60</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.69</ci_lower_limit>
            <ci_upper_limit>-2.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Aβ 1-42</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-65.41</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-72.23</ci_lower_limit>
            <ci_upper_limit>-56.92</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Aβ 1-42</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-84.56</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-88.97</ci_lower_limit>
            <ci_upper_limit>-78.38</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 43 days</time_frame>
      <desc>All enrolled participants who received study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Part A, Cohort 1, Placebo</title>
          <description>Participants received placebo identical to LY3323795 orally.</description>
        </group>
        <group group_id="E2">
          <title>Part A, Cohort 1, 0.3 mg LY3323795</title>
          <description>Participants received 0.3 mg of LY3323795 orally.</description>
        </group>
        <group group_id="E3">
          <title>Part A, Cohort 1, 3 mg LY3323795</title>
          <description>Participants received 3 mg of LY3323795 orally.</description>
        </group>
        <group group_id="E4">
          <title>Part A, Cohort 1, 30 mg LY3323795</title>
          <description>Participants received 30 mg of LY3323795 orally.</description>
        </group>
        <group group_id="E5">
          <title>Part A, Cohort 2, Placebo</title>
          <description>Participants received placebo identical to LY3323795 orally.</description>
        </group>
        <group group_id="E6">
          <title>Part A, Cohort 2, 1 mg LY3323795</title>
          <description>Participants received 1 mg of LY3323795 orally.</description>
        </group>
        <group group_id="E7">
          <title>Part A, Cohort 2, 10 mg LY3323795</title>
          <description>Participants received 10 mg of LY3323795 orally.</description>
        </group>
        <group group_id="E8">
          <title>Part A, Cohort 2, 100 mg LY3323795</title>
          <description>Participants received 100 mg of LY3323795 orally.</description>
        </group>
        <group group_id="E9">
          <title>Part B, 6 mg LY3323795</title>
          <description>Participants received 6 mg of LY3323795 orally.</description>
        </group>
        <group group_id="E10">
          <title>Part B, 20 mg LY3323795</title>
          <description>Participants received 20 mg of LY3323795 orally.</description>
        </group>
        <group group_id="E11">
          <title>Part B, 80 mg LY3323795</title>
          <description>Participants received 80 mg of LY3323795 orally.</description>
        </group>
        <group group_id="E12">
          <title>Part B, Placebo</title>
          <description>Participants received placebo identical to LY3323795 orally.</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="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 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="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Diarrhoea haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Vessel puncture site bruise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Post lumbar puncture syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Procedural complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Procedural headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Procedural nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Procedural vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Part C (an itraconazole interaction study) was not initiated due to a Lilly internal strategy decision.</limitations_and_caveats>
    <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/NCT02989389
org study id: 16610
secondary id: I9F-MC-SCAA
nct id: NCT02989389
lead sponsor: 
has dmc: No
The main purpose of this study is to investigate the safety of LY3323795 and the effects it
      has on the body. The study drug or placebo (sugar pill) will be given by mouth to healthy
      participants. The study has three parts. Each participant may only enroll in one part. The
      study will last 14 to 43 days, depending on the part. Screening must be completed prior to
      study start.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
time frame: Baseline to Study Completion (up to Day 43)
description: Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 19.1. A summary of non-serious adverse events and all serious adverse events, regardless of causality is located in the Reported Adverse Events section.
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3323795 in Plasma
time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72,96,120,144 hours, post dose
description: Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3323795 in plasma.
measure: Part B Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3323795 in Cerebrospinal Fluid (CSF)
time frame: -4, -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36 hours, post dose
description: Part B Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3323795 in cerebrospinal fluid (CSF).
measure: Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3323795 in Plasma
time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72,96,120,144 hours, post dose
description: Pharmacokinetics (PK): Area under the concentration time curve from time zero to tlast (AUC[0-tlast]) of LY3323795 in plasma.
measure: Part B Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3323795 in Cerebrospinal Fluid (CSF)
time frame: -4, -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36 hours, post dose
description: Part B Pharmacokinetics (PK): Area under the concentration time curve from time zero to tlast (AUC[0-tlast]) of LY3323795 in cerebrospinal fluid (CSF).
measure: Pharmacodynamics (PD): Change From Baseline in Plasma Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂
time frame: Baseline through 144 hours
description: Amyloid beta is a peptide fragment of the amyloid precursor protein, plasma concentrations of Aβ1-40 and Aβ1-42 were determined using validated immunoassay methods.
measure: Part B Pharmacodynamics (PD): Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂
time frame: Baseline through 36 hours
description: Amyloid beta is a peptide fragment of the amyloid precursor protein, CSF concentrations of Aβ1-40, Aβ1-42 were determined using validated immunoassay methods.
arm group label: LY3323795 (Part A)
arm group type: Experimental
description: Participants received escalating doses of 0.3 mg (milligrams), 1 mg, 3 mg, 10 mg, 30 mg and 100 mg of LY3323795 orally.
arm group label: Placebo (Part A)
arm group type: Placebo Comparator
description: Participants received placebo identical to LY3323795 orally.
arm group label: LY3323795 (Part B)
arm group type: Experimental
description: Participants received 6 mg, 20 mg and 80 mg of LY3323795 orally.
arm group label: Placebo (Part B)
arm group type: Placebo Comparator
description: Participants received placebo identical to LY3323795 orally.
arm group label: LY3323795 (Part C)
arm group type: Experimental
description: Part C was not initiated due to a Lilly internal strategy decision.
arm group label: LY3323795 + Itraconazole (Part C)
arm group type: Experimental
description: Part C was not initiated due to a Lilly internal strategy decision.
intervention type: Drug
intervention name: LY3323795
description: Administered orally
arm group label: LY3323795 (Part A)
arm group label: LY3323795 (Part B)
arm group label: LY3323795 (Part C)
arm group label: LY3323795 + Itraconazole (Part C)
intervention type: Drug
intervention name: Itraconazole
description: Administered orally
arm group label: LY3323795 + Itraconazole (Part C)
intervention type: Drug
intervention name: Placebo
description: Administered orally
arm group label: Placebo (Part A)
arm group label: Placebo (Part B)
criteria: 
gender: All
minimum age: 20 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: United States
responsible party type: Sponsor
mesh term: Itraconazole
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Part C (an itraconazole interaction study) was not initiated due to a Lilly internal strategy decision.
point of contact: 