<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/NCT03252015</url>
  </required_header>
  <id_info>
    <org_study_id>16859</org_study_id>
    <secondary_id>H8H-MC-LAHE</secondary_id>
    <nct_id>NCT03252015</nct_id>
  </id_info>
  <brief_title>A Study of Multiple Doses of Lasmiditan in Healthy Participants</brief_title>
  <official_title>Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Drug-Drug Interaction Study of Lasmiditan</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to look at how much lasmiditan, study drug, gets into the blood&#xD;
      stream and how long it takes the body to get rid of it.&#xD;
&#xD;
      When drugs are taken together, one or all of the drugs used in combination may be affected.&#xD;
      This study will also evaluate the concentrations in the blood of a probe drug cocktail taken&#xD;
      alone and in combination with lasmiditan. Information about any side effects that may occur&#xD;
      will also be collected.&#xD;
&#xD;
      The study has two parts. Participants will only enroll in one part. This study will last&#xD;
      about 25 days for group 1 and 22 days for group 2, not including screening. Screening is&#xD;
      required within 28 days prior to the start of the study.&#xD;
&#xD;
      This study is for research purposes only and is not intended to treat any medical condition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">January 2, 2018</completion_date>
  <primary_completion_date type="Actual">January 2, 2018</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>Sequential 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 through 14 days after last administration of study drug</time_frame>
    <description>A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. Adverse events for this outcome measure are reported by arm. SAEs are reported by study drug in the Adverse Events module.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1</measure>
    <time_frame>Lasmiditan PK: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr and 48 hr postdose</time_frame>
    <description>PK: Cmax of lasmiditan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7</measure>
    <time_frame>Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr postdose</time_frame>
    <description>PK: Cmax of lasmiditan Day 7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1</measure>
    <time_frame>Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, and 24hr postdose</time_frame>
    <description>PK: AUCtau of lasmiditan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 7</measure>
    <time_frame>Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr,and 24hr postdose</time_frame>
    <description>PK AUCtau of lasmiditan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score</measure>
    <time_frame>PreDose Day 7 and Day 21</time_frame>
    <description>BWSQ is a 20 item, self administered withdrawal symptom questionnaire. Each question is scored by a 0 representing no withdrawal symptoms, 1 for moderate symptoms, 2 for severe symptoms. Total score at each time point will be averaged for each treatment in each cohort.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician Withdrawal Checklist (PWC)Total Score</measure>
    <time_frame>Day 7 and Day 21 at anytime</time_frame>
    <description>Physician Withdrawal Checklist (PWC) : 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 1</measure>
    <time_frame>Day 1: 0.5 hr, 1hr, 1.5hr, 2 hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr adn 48 hr postdose</time_frame>
    <description>Cmax of M8 on Day 1 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 7</measure>
    <time_frame>Day 7: Predose, 0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr and 48 hr postdose</time_frame>
    <description>Cmax of M8 on Day 7 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam</measure>
    <time_frame>Day -3: Predose, 0.5 hour(hr), 1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose,</time_frame>
    <description>PK: Cmax of midazolam.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam on Day 7</measure>
    <time_frame>Day 7:Predose, 0,5hr,1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose</time_frame>
    <description>PK of midazolam.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Probe Drug Cocktail (Cohort 1a)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Probe Drug Cocktail administered orally on Day -3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>200 milligrams (mg) Lasmiditan+Probe Drug Cocktail (Cohort 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>200 mg lasmiditan administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo+Probe Drug Cocktail (Cohort 1b)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>400 mg Lasmiditan (Cohort 2a)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>400 mg lasmiditan administered orally for 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Cohort 2b)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo administered orally for 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Probe Drug Cocktail</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>200 milligrams (mg) Lasmiditan+Probe Drug Cocktail (Cohort 1)</arm_group_label>
    <arm_group_label>Placebo+Probe Drug Cocktail (Cohort 1b)</arm_group_label>
    <arm_group_label>Probe Drug Cocktail (Cohort 1a)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lasmiditan</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>200 milligrams (mg) Lasmiditan+Probe Drug Cocktail (Cohort 1)</arm_group_label>
    <arm_group_label>400 mg Lasmiditan (Cohort 2a)</arm_group_label>
    <other_name>LY573144</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Placebo (Cohort 2b)</arm_group_label>
    <arm_group_label>Placebo+Probe Drug Cocktail (Cohort 1b)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males or females, as determined by medical history and physical examination&#xD;
&#xD;
          -  Have a body mass index (BMI) of 19.0 to 35.0 kilograms per meter squared (kg/m²)&#xD;
             inclusive, at the time of screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have participated, within the last 30 days, in a clinical study involving an&#xD;
             Investigational Product (IP)&#xD;
&#xD;
          -  Have previously completed or withdrawn from this study or any other study&#xD;
             investigating Lasmiditan, and have previously received Lasmiditan&#xD;
&#xD;
          -  Have clinically significant abnormality in the 12-lead ECG, including corrected QT&#xD;
             interval (QTc) with Fridericia's correction (QTcF) greater than (&gt;) 450 milliseconds&#xD;
             (ms) for men or &gt;470 ms for women or any abnormality that in the opinion of the&#xD;
             investigator increases the risk of participating in the study (not limited to&#xD;
             significant bradycardia or heart block)&#xD;
&#xD;
          -  History of, show evidence of, or are undergoing treatment for significant active&#xD;
             neuropsychiatric disease (for example, manic depressive illness, schizophrenia,&#xD;
             depression), have a recent history of a suicide attempt (30 days within screening&#xD;
             visit and any time between screening visit and baseline); or are clinically judged by&#xD;
             the investigator to be at risk for suicide&#xD;
&#xD;
          -  History of hypoglycemia&#xD;
&#xD;
          -  Known history of glucose-6-phosphate dehydrogenase deficiency&#xD;
&#xD;
          -  Are taking a concomitant medication or a dietary substance that affects cytochrome&#xD;
             P450 (CYP)1A2, CYP2C9, and/or CYP3A isotypes within 14 days of screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance Daytona Beach</name>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <zip>32117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <results_first_submitted>November 8, 2019</results_first_submitted>
  <results_first_submitted_qc>December 20, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 10, 2020</results_first_posted>
  <last_update_submitted>December 20, 2019</last_update_submitted>
  <last_update_submitted_qc>December 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 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>Lasmiditan</mesh_term>
  </intervention_browse>
  <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>August 31, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03252015/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>September 11, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03252015/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1a (Placebo+Probe Drug Cocktail)</title>
          <description>Placebo administered alone, orally (PO), on Days 1-6 and concurrently with probe drug cocktail on Day -3 and Day 7.</description>
        </group>
        <group group_id="P2">
          <title>Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)</title>
          <description>Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Days -3 and Day 7.</description>
        </group>
        <group group_id="P3">
          <title>Cohort 2a (Placebo)</title>
          <description>Placebo administered daily PO, Days 1-7.</description>
        </group>
        <group group_id="P4">
          <title>Cohort 2b (400 mg Lasmiditan)</title>
          <description>Daily,oral (PO), 400 mg lasmiditan Days 1-7</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="28"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="28"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="27"/>
                <participants group_id="P3" count="14"/>
                <participants group_id="P4" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants who received at least 1 dose of study drug</population>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1a (Placebo+Probe Drug Cocktail)</title>
          <description>Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.</description>
        </group>
        <group group_id="B2">
          <title>Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)</title>
          <description>Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.</description>
        </group>
        <group group_id="B3">
          <title>Cohort 2a (Placebo)</title>
          <description>Placebo administered daily PO, Days 1-7.</description>
        </group>
        <group group_id="B4">
          <title>Cohort 2b (400 mg Lasmiditan)</title>
          <description>Daily,oral (PO), 400 mg lasmiditan Days 1-7</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="15"/>
            <count group_id="B4" value="15"/>
            <count group_id="B5" value="70"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.8" spread="11.9"/>
                    <measurement group_id="B2" value="42.9" spread="12.3"/>
                    <measurement group_id="B3" value="39.5" spread="11.4"/>
                    <measurement group_id="B4" value="36.9" spread="9.7"/>
                    <measurement group_id="B5" value="40.9" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="40"/>
                  </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="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="39"/>
                  </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_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_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_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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                  </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_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="12"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kilograms (kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.78" spread="13.14"/>
                    <measurement group_id="B2" value="81.92" spread="13.72"/>
                    <measurement group_id="B3" value="74.13" spread="11.04"/>
                    <measurement group_id="B4" value="78.95" spread="14.67"/>
                    <measurement group_id="B5" value="78.39" spread="13.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kilograms per meter squared</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.17" spread="2.54"/>
                    <measurement group_id="B2" value="28.18" spread="3.51"/>
                    <measurement group_id="B3" value="25.87" spread="3.32"/>
                    <measurement group_id="B4" value="27.14" spread="3.88"/>
                    <measurement group_id="B5" value="27.29" spread="3.45"/>
                  </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>A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. Adverse events for this outcome measure are reported by arm. SAEs are reported by study drug in the Adverse Events module.</description>
        <time_frame>Baseline through 14 days after last administration of study drug</time_frame>
        <population>All participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1a (Placebo+Probe Drug Cocktail)</title>
            <description>Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)</title>
            <description>Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2a (Placebo)</title>
            <description>Placebo administered daily PO, Days 1-7.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2b (400 mg Lasmiditan)</title>
            <description>Daily,oral (PO), 400 mg lasmiditan Days 1-7</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>A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. Adverse events for this outcome measure are reported by arm. SAEs are reported by study drug in the Adverse Events module.</description>
          <population>All participants who received at least 1 dose of 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="12"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
              </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1</title>
        <description>PK: Cmax of lasmiditan</description>
        <time_frame>Lasmiditan PK: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr and 48 hr postdose</time_frame>
        <population>All participants who received at least 1 dose of lasmiditan on Day 1 and had evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>200 mg Lasmiditan</title>
            <description>Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.</description>
          </group>
          <group group_id="O2">
            <title>400 mg Lasmiditan</title>
            <description>Daily,oral (PO), 400 mg lasmiditan Days 1-7</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1</title>
          <description>PK: Cmax of lasmiditan</description>
          <population>All participants who received at least 1 dose of lasmiditan on Day 1 and had evaluable PK data.</population>
          <units>nanograms 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="28"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="349" spread="32"/>
                    <measurement group_id="O2" value="750" spread="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7</title>
        <description>PK: Cmax of lasmiditan Day 7</description>
        <time_frame>Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr postdose</time_frame>
        <population>All participants who received at least 1 dose of lasmiditan on Day 7 and had evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>200 mg Lasmiditan</title>
            <description>Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.</description>
          </group>
          <group group_id="O2">
            <title>400 mg Lasmiditan</title>
            <description>Daily,oral (PO), 400 mg lasmiditan Days 1-7</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7</title>
          <description>PK: Cmax of lasmiditan Day 7</description>
          <population>All participants who received at least 1 dose of lasmiditan on Day 7 and had evaluable PK data.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="353" spread="29"/>
                    <measurement group_id="O2" value="808" spread="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1</title>
        <description>PK: AUCtau of lasmiditan</description>
        <time_frame>Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, and 24hr postdose</time_frame>
        <population>All participants who received at least 1 dose of lasmiditan on Day 1 and had evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)</title>
            <description>Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Days -3 and Day 7..</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2b (400 mg Lasmiditan)</title>
            <description>Daily,oral (PO), 400 mg lasmiditan Days 1-7</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1</title>
          <description>PK: AUCtau of lasmiditan</description>
          <population>All participants who received at least 1 dose of lasmiditan on Day 1 and had evaluable PK data.</population>
          <units>nanograms times hour per milliLiter</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="28"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2070" spread="32"/>
                    <measurement group_id="O2" value="4530" spread="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 7</title>
        <description>PK AUCtau of lasmiditan</description>
        <time_frame>Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr,and 24hr postdose</time_frame>
        <population>All participants who received at least 1 dose of lasmiditan on Day 1 and had evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>200 mg Lasmiditan+Probe Drug Cocktail (Cohort 1)</title>
            <description>Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.</description>
          </group>
          <group group_id="O2">
            <title>400 mg Lasmiditan (Cohort 2)</title>
            <description>Daily,oral (PO), 400 mg lasmiditan Days 1-7</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 7</title>
          <description>PK AUCtau of lasmiditan</description>
          <population>All participants who received at least 1 dose of lasmiditan on Day 1 and had evaluable PK data.</population>
          <units>nanograms time hours per milliLiter</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="26"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2160" spread="29"/>
                    <measurement group_id="O2" value="4690" spread="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score</title>
        <description>BWSQ is a 20 item, self administered withdrawal symptom questionnaire. Each question is scored by a 0 representing no withdrawal symptoms, 1 for moderate symptoms, 2 for severe symptoms. Total score at each time point will be averaged for each treatment in each cohort.</description>
        <time_frame>PreDose Day 7 and Day 21</time_frame>
        <population>All participants who received at least 1 dose of study drug and completed the questionnaire.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1a (Placebo+Probe Drug Cocktail)</title>
            <description>Placebo administered alone, orally (PO), on Days 1-6 and concurrently with probe drug cocktail on Day -3 and Day 7.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)</title>
            <description>Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Days -3 and Day 7..</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2a (Placebo)</title>
            <description>Placebo administered daily PO, Days 1-7.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2b (400 mg Lasmiditan)</title>
            <description>Daily,oral (PO), 400 mg lasmiditan Days 1-7</description>
          </group>
        </group_list>
        <measure>
          <title>Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score</title>
          <description>BWSQ is a 20 item, self administered withdrawal symptom questionnaire. Each question is scored by a 0 representing no withdrawal symptoms, 1 for moderate symptoms, 2 for severe symptoms. Total score at each time point will be averaged for each treatment in each cohort.</description>
          <population>All participants who received at least 1 dose of study drug and completed the questionnaire.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.0"/>
                    <measurement group_id="O2" value="0.2" spread="0.6"/>
                    <measurement group_id="O3" value="0.0" spread="0.0"/>
                    <measurement group_id="O4" value="0.1" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.0"/>
                    <measurement group_id="O2" value="0.0" spread="0.0"/>
                    <measurement group_id="O3" value="0.0" spread="0.0"/>
                    <measurement group_id="O4" value="0.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 7</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.182</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.412</ci_lower_limit>
            <ci_upper_limit>0.049</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.071</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.081</ci_lower_limit>
            <ci_upper_limit>0.224</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.000</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.000</ci_lower_limit>
            <ci_upper_limit>0.000</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.000</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.000</ci_lower_limit>
            <ci_upper_limit>0.000</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physician Withdrawal Checklist (PWC)Total Score</title>
        <description>Physician Withdrawal Checklist (PWC) : 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.</description>
        <time_frame>Day 7 and Day 21 at anytime</time_frame>
        <population>All participants who received at least 1 dose of study drug and had completed the questionnaire.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1a (Placebo+Probe Drug Cocktail)</title>
            <description>Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)</title>
            <description>Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2a (Placebo)</title>
            <description>Placebo administered daily PO, Days 1-7.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2b (400 mg Lasmiditan)</title>
            <description>Daily,oral (PO), 400 mg lasmiditan Days 1-7</description>
          </group>
        </group_list>
        <measure>
          <title>Physician Withdrawal Checklist (PWC)Total Score</title>
          <description>Physician Withdrawal Checklist (PWC) : 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.</description>
          <population>All participants who received at least 1 dose of study drug and had completed the questionnaire.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7 Predose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.4"/>
                    <measurement group_id="O2" value="0.0" spread="0.2"/>
                    <measurement group_id="O3" value="0.0" spread="0.0"/>
                    <measurement group_id="O4" value="0.1" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.0"/>
                    <measurement group_id="O2" value="0.1" spread="0.4"/>
                    <measurement group_id="O3" value="0.0" spread="0.0"/>
                    <measurement group_id="O4" value="0.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 7</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.145</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.340</ci_lower_limit>
            <ci_upper_limit>0.050</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.071</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.081</ci_lower_limit>
            <ci_upper_limit>0.224</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.071</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.151</ci_lower_limit>
            <ci_upper_limit>0.294</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.000</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.000</ci_lower_limit>
            <ci_upper_limit>0.000</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 1</title>
        <description>Cmax of M8 on Day 1 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan.</description>
        <time_frame>Day 1: 0.5 hr, 1hr, 1.5hr, 2 hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr adn 48 hr postdose</time_frame>
        <population>All participant who received at least 1 dose of lasmiditan and had evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>200 mg Lasmiditan</title>
            <description>Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7</description>
          </group>
          <group group_id="O2">
            <title>400 mg Lasmiditan</title>
            <description>Daily,oral (PO), 400 mg lasmiditan Days 1-7</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 1</title>
          <description>Cmax of M8 on Day 1 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan.</description>
          <population>All participant who received at least 1 dose of lasmiditan and had evaluable PK data.</population>
          <units>mg/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="28"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="407" spread="24"/>
                    <measurement group_id="O2" value="964" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 7</title>
        <description>Cmax of M8 on Day 7 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan.</description>
        <time_frame>Day 7: Predose, 0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr and 48 hr postdose</time_frame>
        <population>All participants who received at least one dose of lasmiditan and had evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>200 mg Lasmiditan+Probe Drug Cocktail (Cohort 1)</title>
            <description>Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.</description>
          </group>
          <group group_id="O2">
            <title>400 mg Lasmiditan (Cohort 2)</title>
            <description>Daily,oral (PO), 400 mg lasmiditan Days 1-7</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 7</title>
          <description>Cmax of M8 on Day 7 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan.</description>
          <population>All participants who received at least one dose of lasmiditan and had evaluable PK data.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="641" spread="20"/>
                    <measurement group_id="O2" value="1500" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam</title>
        <description>PK: Cmax of midazolam.</description>
        <time_frame>Day -3: Predose, 0.5 hour(hr), 1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose,</time_frame>
        <population>All randomized participant who received midazolam on Day -3 and had evaluable PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received Probe Drug Cocktail</title>
            <description>Probe drug cocktail was administered PO alone to all participants on Day -3.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam</title>
          <description>PK: Cmax of midazolam.</description>
          <population>All randomized participant who received midazolam on Day -3 and had evaluable PK parameters.</population>
          <units>nanograms per milliLiter</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="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10." spread="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam on Day 7</title>
        <description>PK of midazolam.</description>
        <time_frame>Day 7:Predose, 0,5hr,1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose</time_frame>
        <population>All randomized participant who received midazolam on Day 7 and had evaluable PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1a (Placebo+Probe Drug Cocktail)</title>
            <description>Placebo administered alone, orally (PO), on Days 1-6 and concurrently with probe drug cocktail on Day -3 and Day 7.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)</title>
            <description>Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Days -3 and Day 7.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam on Day 7</title>
          <description>PK of midazolam.</description>
          <population>All randomized participant who received midazolam on Day 7 and had evaluable PK parameters.</population>
          <units>nanograms per milliliter</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="11"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" spread="40"/>
                    <measurement group_id="O2" value="9.45" spread="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline through 28 days</time_frame>
      <desc>All participants who received at least 1 dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Probe Drug Cocktail (Cohort 1)</title>
          <description>Probe drug cocktail administered on Day 13 and Day 7</description>
        </group>
        <group group_id="E2">
          <title>200 mg Lasmiditan QD (Cohort 1)</title>
          <description>Daily,oral (PO), 200 mg lasmiditan Days 1-6</description>
        </group>
        <group group_id="E3">
          <title>200 mg Lasmiditan QD + Probe Drug Cocktail (Cohort 1)</title>
          <description>Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.</description>
        </group>
        <group group_id="E4">
          <title>Placebo QD (Cohort 1)</title>
          <description>Placebo administered daily PO, Days 1-7</description>
        </group>
        <group group_id="E5">
          <title>Placebo QD + Probe Drug Cocktail (Cohort 1)</title>
          <description>Placebo administered alone, orally (PO), on Days 1-6 and concurrently with probe drug cocktail on Day -3 and Day 7</description>
        </group>
        <group group_id="E6">
          <title>400 mg Lasmiditan QD (Cohort 2)</title>
          <description>Daily,oral (PO), 400 mg lasmiditan Days 1-7</description>
        </group>
        <group group_id="E7">
          <title>Placebo QD (Cohort 2)</title>
          <description>Placebo administered daily PO, Days 1-7</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="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Nodal rhythm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Wrong technique in product usage process</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="7" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Euphoric mood</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Libido decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Nervousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Cheif 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/NCT03252015
org study id: 16859
secondary id: H8H-MC-LAHE
nct id: NCT03252015
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to look at how much lasmiditan, study drug, gets into the blood
      stream and how long it takes the body to get rid of it.

      When drugs are taken together, one or all of the drugs used in combination may be affected.
      This study will also evaluate the concentrations in the blood of a probe drug cocktail taken
      alone and in combination with lasmiditan. Information about any side effects that may occur
      will also be collected.

      The study has two parts. Participants will only enroll in one part. This study will last
      about 25 days for group 1 and 22 days for group 2, not including screening. Screening is
      required within 28 days prior to the start of the study.

      This study is for research purposes only and is not intended to treat any medical condition.
allocation: Randomized
intervention model: Sequential 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 through 14 days after last administration of study drug
description: A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. Adverse events for this outcome measure are reported by arm. SAEs are reported by study drug in the Adverse Events module.
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1
time frame: Lasmiditan PK: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr and 48 hr postdose
description: PK: Cmax of lasmiditan
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7
time frame: Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr postdose
description: PK: Cmax of lasmiditan Day 7
measure: Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1
time frame: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, and 24hr postdose
description: PK: AUCtau of lasmiditan
measure: Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 7
time frame: Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr,and 24hr postdose
description: PK AUCtau of lasmiditan
measure: Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score
time frame: PreDose Day 7 and Day 21
description: BWSQ is a 20 item, self administered withdrawal symptom questionnaire. Each question is scored by a 0 representing no withdrawal symptoms, 1 for moderate symptoms, 2 for severe symptoms. Total score at each time point will be averaged for each treatment in each cohort.
measure: Physician Withdrawal Checklist (PWC)Total Score
time frame: Day 7 and Day 21 at anytime
description: Physician Withdrawal Checklist (PWC) : 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 1
time frame: Day 1: 0.5 hr, 1hr, 1.5hr, 2 hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr adn 48 hr postdose
description: Cmax of M8 on Day 1 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan.
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 7
time frame: Day 7: Predose, 0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr and 48 hr postdose
description: Cmax of M8 on Day 7 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan.
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam
time frame: Day -3: Predose, 0.5 hour(hr), 1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose,
description: PK: Cmax of midazolam.
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam on Day 7
time frame: Day 7:Predose, 0,5hr,1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose
description: PK of midazolam.
arm group label: Probe Drug Cocktail (Cohort 1a)
arm group type: Experimental
description: Probe Drug Cocktail administered orally on Day -3.
arm group label: 200 milligrams (mg) Lasmiditan+Probe Drug Cocktail (Cohort 1)
arm group type: Experimental
description: 200 mg lasmiditan administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.
arm group label: Placebo+Probe Drug Cocktail (Cohort 1b)
arm group type: Placebo Comparator
description: Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.
arm group label: 400 mg Lasmiditan (Cohort 2a)
arm group type: Experimental
description: 400 mg lasmiditan administered orally for 7 days.
arm group label: Placebo (Cohort 2b)
arm group type: Experimental
description: Placebo administered orally for 7 days.
intervention type: Drug
intervention name: Probe Drug Cocktail
description: Administered orally
arm group label: 200 milligrams (mg) Lasmiditan+Probe Drug Cocktail (Cohort 1)
arm group label: Placebo+Probe Drug Cocktail (Cohort 1b)
arm group label: Probe Drug Cocktail (Cohort 1a)
intervention type: Drug
intervention name: Lasmiditan
description: Administered orally
arm group label: 200 milligrams (mg) Lasmiditan+Probe Drug Cocktail (Cohort 1)
arm group label: 400 mg Lasmiditan (Cohort 2a)
other name: LY573144
intervention type: Drug
intervention name: Placebo
description: Administered orally
arm group label: Placebo (Cohort 2b)
arm group label: Placebo+Probe Drug Cocktail (Cohort 1b)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lasmiditan
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 