<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/NCT02233296</url>
  </required_header>
  <id_info>
    <org_study_id>16905</org_study_id>
    <secondary_id>H8H-CD-LAHR</secondary_id>
    <secondary_id>COL MIG-104</secondary_id>
    <nct_id>NCT02233296</nct_id>
  </id_info>
  <brief_title>Food-Effect Study in Healthy Participants</brief_title>
  <official_title>A Randomized Open Label Study to Compare the Bioavailability of Lasmiditan 200 mg Under Fed and Fasted Conditions in Healthy Male and Female Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CoLucid Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </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>
      This study will evaluate the effect of food on the pharmacokinetics (PK) of a single dose of&#xD;
      lasmiditan in healthy participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An open-label, cross-over, two-period, randomized, sequential study in order to investigate&#xD;
      the effect of food on the pharmacokinetics of lasmiditan 200 mg. Two single doses of&#xD;
      lasmiditan will be administered with the participants in fed and fasted states.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics - Cmax (ng/mL)</measure>
    <time_frame>Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)</time_frame>
    <description>This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics - Tmax (Hours)</measure>
    <time_frame>Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)</time_frame>
    <description>This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics - AUC0-t (ng.h/mL)</measure>
    <time_frame>Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)</time_frame>
    <description>This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics - AUC0-inf (ng.h/mL)</measure>
    <time_frame>Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)</time_frame>
    <description>This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety. Safety Measurements Include Physical Exams, Vital Signs, ECGs, Clinical Laboratory Assessments, AEs, Columbia Suicide Severity Rating Scale (C-SSRS).</measure>
    <time_frame>Duration of study- From Screening (signing informed consent form) to End-of-Study ~ 15 days</time_frame>
    <description>Safety was evaluated in all participants (n=30) under the fasted condition and the fed condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed). The number of unique subjects with an AE and the number of events are provided.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability</measure>
    <time_frame>15 days</time_frame>
    <description>Tolerability was defined as the number of participants that did not withdraw from the study early due to adverse events.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dosing Sequence: Administration of lasmiditan 200 mg in fed state in Dosing Period 1 followed by administration of lasmiditan 200 mg in fasted state in Dosing Period 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dosing Sequence: Administration of lasmiditan 200 mg in fasted state in Dosing Period 1 followed by administration in lasmiditan 200 mg fed state in Dosing Period 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lasmiditan</intervention_name>
    <description>2 discrete doses separated by 6 days.</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <other_name>COL-144</other_name>
    <other_name>LY573144</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged 18-50 years.&#xD;
&#xD;
          -  Able and willing to give written informed consent.&#xD;
&#xD;
          -  Females of child bearing potential must be using or willing to use a medically&#xD;
             acceptable method (as defined by the Investigator) of birth control.&#xD;
&#xD;
          -  Body mass index (BMI) within 19 and 29.9 kilograms per meter squared (kg/m²).&#xD;
&#xD;
          -  No clinically significant abnormalities (as determined by the Principal Investigator)&#xD;
             in hematology, blood chemistry and urinalysis lab tests at screening.&#xD;
&#xD;
          -  No history of alcohol or drug abuse within the past year. Negative urinary drugs of&#xD;
             abuse and alcohol screen determined within 21 days of the start of the study and at&#xD;
             check-in Day -1.&#xD;
&#xD;
          -  Must be able to understand the requirements of the study and must be willing to comply&#xD;
             with the requirements of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any medical condition or clinical laboratory test which in the judgment of the&#xD;
             Investigator makes the participant unsuitable for the study.&#xD;
&#xD;
          -  Pregnant or breast-feeding women.&#xD;
&#xD;
          -  Use of any prescription within 14 days prior to dosing (except hormonal&#xD;
             contraceptives) or over the-counter medications, including vitamins and herbal or&#xD;
             dietary supplements within 7 days prior to dosing unless approved by the Investigator&#xD;
             and Medical Monitor.&#xD;
&#xD;
          -  History within the previous 3 years or current evidence of abuse of any drug,&#xD;
             prescription or illicit, or alcohol; a positive urine screen for drugs of abuse or&#xD;
             alcohol.&#xD;
&#xD;
          -  History of orthostatic hypotension with or without syncope.&#xD;
&#xD;
          -  At imminent risk of suicide (positive response to question 4 or 5 on the&#xD;
             Columbia-Suicide Severity Rating Scale [C-SSRS]) or had a suicide attempt within 6&#xD;
             months prior to screening.&#xD;
&#xD;
          -  Participation in any clinical trial of an experimental drug or device in the previous&#xD;
             30 days.&#xD;
&#xD;
          -  Positive Hepatitis C antibody, Hepatitis B surface antigen, or positive human&#xD;
             immunodeficiency virus (HIV) antibody.&#xD;
&#xD;
          -  Donated plasma in the 7 days or blood in the 3 months preceding study drug&#xD;
             administration.&#xD;
&#xD;
          -  Inability to communicate well with the Investigator and study staff (i.e., language&#xD;
             problem, poor mental development or impaired cerebral function).&#xD;
&#xD;
          -  Inability to fast or consume the food provided in the study.&#xD;
&#xD;
          -  Relatives of, or staff directly reporting to, the Investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 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>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <results_first_submitted>February 2, 2016</results_first_submitted>
  <results_first_submitted_qc>August 19, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 22, 2016</results_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lasmiditan</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Fifty one (51) healthy participants were recruited according to the procedures of the Phase 1 unit. Thirty four were determined to be eligible. Thirty participants entered and completed the study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Group A</title>
          <description>Dosing Sequence: Administration of lasmiditan 200 mg in fed state in Dosing Period 1 followed by administration of lasmiditan 200 mg in fasted state in Dosing Period 2&#xD;
Lasmiditan: 2 discrete doses separated by 6 days.</description>
        </group>
        <group group_id="P2">
          <title>Group B</title>
          <description>Dosing Sequence: Administration of lasmiditan 200 mg in fasted state in Dosing Period 1 followed by administration in lasmiditan 200 mg fed state in Dosing Period 2.&#xD;
Lasmiditan: 2 discrete doses separated by 6 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>healthy male and female participants aged 18-</population>
      <group_list>
        <group group_id="B1">
          <title>Group A</title>
          <description>Dosing Sequence: Administration of lasmiditan 200 mg in fed state in Dosing Period 1 followed by administration of lasmiditan 200 mg in fasted state in Dosing Period 2&#xD;
Lasmiditan: 2 discrete doses separated by 6 days.</description>
        </group>
        <group group_id="B2">
          <title>Group B</title>
          <description>Dosing Sequence: Administration of lasmiditan 200 mg in fasted state in Dosing Period 1 followed by administration in lasmiditan 200 mg fed state in Dosing Period 2.&#xD;
Lasmiditan: 2 discrete doses separated by 6 days.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_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="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics - Cmax (ng/mL)</title>
        <description>This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).</description>
        <time_frame>Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)</time_frame>
        <population>all participants with evaluable PK data according to the following criteria:&#xD;
completion of both treatment regimens,&#xD;
availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),&#xD;
absence of any important protocol deviation that would have rendered the data incomparable between treatments</population>
        <group_list>
          <group group_id="O1">
            <title>Fed Condition</title>
            <description>Participants were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.</description>
          </group>
          <group group_id="O2">
            <title>Fasted Condition</title>
            <description>Participants were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics - Cmax (ng/mL)</title>
          <description>This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).</description>
          <population>all participants with evaluable PK data according to the following criteria:&#xD;
completion of both treatment regimens,&#xD;
availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),&#xD;
absence of any important protocol deviation that would have rendered the data incomparable between treatments</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="394.7" spread="168.7"/>
                    <measurement group_id="O2" value="322.8" spread="122.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics - Tmax (Hours)</title>
        <description>This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).</description>
        <time_frame>Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)</time_frame>
        <population>all participants with evaluable PK data according to the following criteria:&#xD;
completion of both treatment regimens,&#xD;
availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),&#xD;
absence of any important protocol deviation that would have rendered the data incomparable between treatments</population>
        <group_list>
          <group group_id="O1">
            <title>Fed Condition</title>
            <description>Participants were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.</description>
          </group>
          <group group_id="O2">
            <title>Fasted Condition</title>
            <description>Participants were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics - Tmax (Hours)</title>
          <description>This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).</description>
          <population>all participants with evaluable PK data according to the following criteria:&#xD;
completion of both treatment regimens,&#xD;
availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),&#xD;
absence of any important protocol deviation that would have rendered the data incomparable between treatments</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="1.0"/>
                    <measurement group_id="O2" value="1.5" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety. Safety Measurements Include Physical Exams, Vital Signs, ECGs, Clinical Laboratory Assessments, AEs, Columbia Suicide Severity Rating Scale (C-SSRS).</title>
        <description>Safety was evaluated in all participants (n=30) under the fasted condition and the fed condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed). The number of unique subjects with an AE and the number of events are provided.</description>
        <time_frame>Duration of study- From Screening (signing informed consent form) to End-of-Study ~ 15 days</time_frame>
        <population>All the participants included in the study who received at least one dose of lasmiditan (n=30). Adverse events were considered in all participants under the fed condition and then in all participants under the fasted condition not per sequence of dosing (fed/fasted or fasted/fed).</population>
        <group_list>
          <group group_id="O1">
            <title>Fed Condition</title>
            <description>Data presented is all participants in the fed condition not by sequence of assigned cross-over (fed/fasted or fasted/fed).</description>
          </group>
          <group group_id="O2">
            <title>Fasted Condition</title>
            <description>Data presented is all participants in the fasted condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed).</description>
          </group>
        </group_list>
        <measure>
          <title>Safety. Safety Measurements Include Physical Exams, Vital Signs, ECGs, Clinical Laboratory Assessments, AEs, Columbia Suicide Severity Rating Scale (C-SSRS).</title>
          <description>Safety was evaluated in all participants (n=30) under the fasted condition and the fed condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed). The number of unique subjects with an AE and the number of events are provided.</description>
          <population>All the participants included in the study who received at least one dose of lasmiditan (n=30). Adverse events were considered in all participants under the fed condition and then in all participants under the fasted condition not per sequence of dosing (fed/fasted or fasted/fed).</population>
          <units>participants with adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tolerability</title>
        <description>Tolerability was defined as the number of participants that did not withdraw from the study early due to adverse events.</description>
        <time_frame>15 days</time_frame>
        <population>All the participants included in the study who received at least one dose of lasmiditan (n=30). Participant disposition was considered for all participants under the fed condition and then all participants under the fasted condition not per sequence of dosing (fed/fasted or fasted/fed).</population>
        <group_list>
          <group group_id="O1">
            <title>Fed Condition (n=30)</title>
            <description>Data presented is all participants in the fed condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed).</description>
          </group>
          <group group_id="O2">
            <title>Fasted Condition (n=30)</title>
            <description>Data presented is all participants in the fasted condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed).</description>
          </group>
        </group_list>
        <measure>
          <title>Tolerability</title>
          <description>Tolerability was defined as the number of participants that did not withdraw from the study early due to adverse events.</description>
          <population>All the participants included in the study who received at least one dose of lasmiditan (n=30). Participant disposition was considered for all participants under the fed condition and then all participants under the fasted condition not per sequence of dosing (fed/fasted or fasted/fed).</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>early withdrawals</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>completers</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics - AUC0-t (ng.h/mL)</title>
        <description>This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).</description>
        <time_frame>Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)</time_frame>
        <population>all participantss with evaluable PK data according to the following criteria:&#xD;
completion of both treatment regimens,&#xD;
availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),&#xD;
absence of any important protocol deviation that would have rendered the data incomparable between treatments</population>
        <group_list>
          <group group_id="O1">
            <title>Fed Condition</title>
            <description>Participants were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.</description>
          </group>
          <group group_id="O2">
            <title>Fasted Condition</title>
            <description>Participants were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics - AUC0-t (ng.h/mL)</title>
          <description>This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).</description>
          <population>all participantss with evaluable PK data according to the following criteria:&#xD;
completion of both treatment regimens,&#xD;
availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),&#xD;
absence of any important protocol deviation that would have rendered the data incomparable between treatments</population>
          <units>ng.h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2244" spread="926.2"/>
                    <measurement group_id="O2" value="1892" spread="746"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics - AUC0-inf (ng.h/mL)</title>
        <description>This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).</description>
        <time_frame>Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)</time_frame>
        <population>all participants with evaluable PK data according to the following criteria:&#xD;
completion of both treatment regimens,&#xD;
availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),&#xD;
absence of any important protocol deviation that would have rendered the data incomparable between treatments</population>
        <group_list>
          <group group_id="O1">
            <title>Fed Condition</title>
            <description>Participants were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.</description>
          </group>
          <group group_id="O2">
            <title>Fasted Condition</title>
            <description>Participants were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics - AUC0-inf (ng.h/mL)</title>
          <description>This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).</description>
          <population>all participants with evaluable PK data according to the following criteria:&#xD;
completion of both treatment regimens,&#xD;
availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),&#xD;
absence of any important protocol deviation that would have rendered the data incomparable between treatments</population>
          <units>ng.h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2265" spread="938.1"/>
                    <measurement group_id="O2" value="1906" spread="751.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From signing informed consent form (ICF) to End-of-study Visit (15 days).</time_frame>
      <desc>AEs are collected from ICF until the completion of EoS/Visit 4. AEs reported prior to dosing were captured and considered non TEAEs. AEs reported more than 48 hours after dosing during the days between Dosing Period 1 and Dosing Period 2 and until the completion of EoS/Visit 4 will be captured and considered non TEAEs.</desc>
      <group_list>
        <group group_id="E1">
          <title>Fed Condition (n=30)</title>
          <description>Participants were randomized to fed/fasted or fasted/fed. Conditions were pooled for analysis so regardless of sequence all AEs reported while participant was in fed condition are considered equally.</description>
        </group>
        <group group_id="E2">
          <title>Fasted Condition (n=30)</title>
          <description>Participants were randomized to fed/fasted or fasted/fed. Conditions were pooled for analysis so regardless of sequence all AEs reported while participant was in fasted condition are considered equally.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Non-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="19" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>ALL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>vision blurred</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>ALL</sub_title>
                <counts group_id="E1" events="24" subjects_affected="18" subjects_at_risk="30"/>
                <counts group_id="E2" events="26" subjects_affected="23" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dizziness - Postural</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="30"/>
                <counts group_id="E2" events="20" subjects_affected="20" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>ALL</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02233296
org study id: 16905
secondary id: H8H-CD-LAHR
secondary id: COL MIG-104
nct id: NCT02233296
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the effect of food on the pharmacokinetics (PK) of a single dose of
      lasmiditan in healthy participants.
An open-label, cross-over, two-period, randomized, sequential study in order to investigate
      the effect of food on the pharmacokinetics of lasmiditan 200 mg. Two single doses of
      lasmiditan will be administered with the participants in fed and fasted states.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetics - Cmax (ng/mL)
time frame: Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)
description: This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).
measure: Pharmacokinetics - Tmax (Hours)
time frame: Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)
description: This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).
measure: Pharmacokinetics - AUC0-t (ng.h/mL)
time frame: Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)
description: This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).
measure: Pharmacokinetics - AUC0-inf (ng.h/mL)
time frame: Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)
description: This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).
measure: Safety. Safety Measurements Include Physical Exams, Vital Signs, ECGs, Clinical Laboratory Assessments, AEs, Columbia Suicide Severity Rating Scale (C-SSRS).
time frame: Duration of study- From Screening (signing informed consent form) to End-of-Study ~ 15 days
description: Safety was evaluated in all participants (n=30) under the fasted condition and the fed condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed). The number of unique subjects with an AE and the number of events are provided.
measure: Tolerability
time frame: 15 days
description: Tolerability was defined as the number of participants that did not withdraw from the study early due to adverse events.
arm group label: Group A
arm group type: Experimental
description: Dosing Sequence: Administration of lasmiditan 200 mg in fed state in Dosing Period 1 followed by administration of lasmiditan 200 mg in fasted state in Dosing Period 2
arm group label: Group B
arm group type: Experimental
description: Dosing Sequence: Administration of lasmiditan 200 mg in fasted state in Dosing Period 1 followed by administration in lasmiditan 200 mg fed state in Dosing Period 2.
intervention type: Drug
intervention name: Lasmiditan
description: 2 discrete doses separated by 6 days.
arm group label: Group A
arm group label: Group B
other name: COL-144
other name: LY573144
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 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
responsible party type: Sponsor
mesh term: Lasmiditan
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 