<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/NCT03040479</url>
  </required_header>
  <id_info>
    <org_study_id>16881</org_study_id>
    <secondary_id>CUD-P9-453</secondary_id>
    <secondary_id>H8H-CD-LAHF</secondary_id>
    <secondary_id>COL MIG-114</secondary_id>
    <nct_id>NCT03040479</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Single Dose Study of Oral Lasmiditan in Participants With Normal and Impaired Hepatic Function</brief_title>
  <official_title>A Phase I, Multicenter, Open-Label, Parallel-Group, Pharmacokinetic Single Dose Study of Oral Lasmiditan in Subjects With Normal and Impaired Hepatic Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Algorithme Pharma Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <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 is a multicenter, open-label, non-randomized, parallel-group, single dose study. This&#xD;
      study will enroll up to 24 participants and will include 2 hepatic impaired participant&#xD;
      groups and one group of control participants with normal hepatic function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will enroll up to 24 participants and will include 2 hepatic impaired participant&#xD;
      groups and one group of control participants with normal hepatic function. Approximately four&#xD;
      participants with mild hepatic impairment will be enrolled first (Group 1). To ensure&#xD;
      participant safety, following dosing of these first four participants, a safety meeting will&#xD;
      take place to review the safety data prior to dosing additional participants. After safety&#xD;
      and pharmacokinetic (PK) results from the first four participants have been reviewed, an&#xD;
      additional four participants with mild hepatic impairment (remainder of Group 1) will be&#xD;
      enrolled concurrently with the moderate hepatic impairment group (Group 2). Thereafter,&#xD;
      matched participants with normal hepatic function (Group 3) will be enrolled. All&#xD;
      participants will participate in one treatment period and will receive a single dose of&#xD;
      lasmiditan in the fasting state.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 14, 2017</start_date>
  <completion_date type="Actual">July 17, 2017</completion_date>
  <primary_completion_date type="Actual">July 17, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a multicenter, open-label, non-randomized, parallel-group, single dose study.&#xD;
This study will enroll up to 24 participants and will include 2 hepatic impaired participant groups and one group of control participants with normal hepatic function.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose</time_frame>
    <description>Maximum observed plasma concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose</time_frame>
    <description>Time of maximum observed plasma concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast])</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose</time_frame>
    <description>Cumulative area under the plasma concentration time curve calculated from 0 to TLQC using the linear trapezoidal method, where TLQC represents time of last observed quantifiable plasma concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf])</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose</time_frame>
    <description>Area under the plasma concentration time curve extrapolated to infinity, calculated as AUC(0-tlast) + CLQC/λZ, where CLQC is the measured concentration at time TLQC Apparent elimination rate constant and λz is the estimated by linear regression of the terminal linear portion of the log concentration versus time curve.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: Apparent Elimination Rate Constant (λZ)</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose</time_frame>
    <description>Apparent elimination rate constant, estimated by linear regression of the terminal linear portion of the log concentration versus time curve.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: Terminal Elimination Half-life (T1/2)</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose</time_frame>
    <description>Terminal elimination half-life, calculated as ln(2)/λZ.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Up To 35 days</time_frame>
    <description>Safety assessed from time of consent through end of study (up to 35 days). A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the Adverse Events module of this record.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Migraine</condition>
  <arm_group>
    <arm_group_label>Mild hepatic impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>lasmiditan 200 mg single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate hepatic impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>lasmiditan 200 mg single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>lasmiditan 200 mg single dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lasmiditan 200 mg</intervention_name>
    <description>single dose</description>
    <arm_group_label>Healthy participants</arm_group_label>
    <arm_group_label>Mild hepatic impairment</arm_group_label>
    <arm_group_label>Moderate hepatic impairment</arm_group_label>
    <other_name>LY573144</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All participants:&#xD;
&#xD;
          -  Availability for the entire study period&#xD;
&#xD;
          -  Motivated participant and absence of intellectual problems likely to limit the&#xD;
             validity of consent to participate in the study or the compliance with protocol&#xD;
             requirements; ability to cooperate adequately; ability to understand and observe the&#xD;
             instructions of the physician or designee&#xD;
&#xD;
          -  Male or female participants&#xD;
&#xD;
          -  A female participant of childbearing potential - agrees to use one of the accepted&#xD;
             contraceptive regimens from at least 28 days prior to the drug administration, during&#xD;
             the study and for at least 60 days after the dose.&#xD;
&#xD;
          -  A male participant with sexual partners who are pregnant, possibly pregnant, or who&#xD;
             could become pregnant must be unable to procreate, or agrees to use an accepted&#xD;
             contraceptive regimens from first drug administration until 3 months after the drug&#xD;
             administration.&#xD;
&#xD;
          -  A male participant agrees to refrain from sperm donation from drug administration&#xD;
             until 90 days after the drug administration&#xD;
&#xD;
          -  Participant aged of at least 18 years&#xD;
&#xD;
          -  Participant with a body mass index (BMI) greater than or equal to (≥1) 8.5 kilogram&#xD;
             per square meter (kg/m²)&#xD;
&#xD;
          -  Light-, non- or ex-smokers&#xD;
&#xD;
          -  Willingness to adhere to the protocol requirements as evidenced by the informed&#xD;
             consent form (ICF)&#xD;
&#xD;
        Participants with Normal Hepatic Function:&#xD;
&#xD;
          -  Clinical laboratory values within the laboratory's stated normal range; if not within&#xD;
             this range, these must be without any clinical significance&#xD;
&#xD;
          -  Have no clinically significant diseases captured in the medical history or evidence of&#xD;
             clinically significant findings on physical examination and/or clinical laboratory&#xD;
             evaluations (hematology, general biochemistry, endocrinology, electrocardiogram [ECG],&#xD;
             and urinalysis)&#xD;
&#xD;
          -  Must match by gender, as well as to the pooled mean values for age (± 10 years) and&#xD;
             weight (± 20%) of participants with hepatic impairment&#xD;
&#xD;
        Hepatic Impaired Participants:&#xD;
&#xD;
          -  Considered clinically stable in the opinion of the Investigator&#xD;
&#xD;
          -  Presence of mild hepatic impairment (Child-Pugh Class A: 5-6 points) or moderate&#xD;
             hepatic impairment (Child-Pugh Class B: 7-9 points) at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All Participants:&#xD;
&#xD;
          -  Females who are pregnant or are lactating&#xD;
&#xD;
          -  History of significant hypersensitivity to lasmiditan or any related products&#xD;
             (including excipients of the formulations) as well as severe hypersensitivity&#xD;
             reactions (like angioedema) to any drugs&#xD;
&#xD;
          -  Suicidal tendency, history of or disposition to seizures, state of confusion,&#xD;
             clinically relevant psychiatric diseases&#xD;
&#xD;
          -  Participant is at imminent risk of suicide (positive response to question 4 or 5 on&#xD;
             the Columbia- Suicide Severity Rating Scale [C-SSRS]) or had a suicide attempt within&#xD;
             6 months prior to screening&#xD;
&#xD;
          -  Presence or history of any disorder (including Parkinson disease) that could interfere&#xD;
             with completion of the study based on the opinion of the Principal Investigator&#xD;
&#xD;
          -  Any history of tuberculosis and/or prophylaxis for tuberculosis&#xD;
&#xD;
          -  Positive results to human immunodeficiency virus antibody/antigen (HIV Ag/Ab) Combo&#xD;
             tests (and HIV I &amp; II screen at Orlando Clinical Research Center site)&#xD;
&#xD;
          -  Females who are pregnant according to a positive pregnancy test&#xD;
&#xD;
          -  Participants who took lasmiditan in the previous 28 days before Day 1 of this study&#xD;
&#xD;
          -  Participants who took an Investigational Product (in another clinical trial) in the&#xD;
             previous 28 days before day 1 of this study&#xD;
&#xD;
          -  Participants who have already participated in this clinical study&#xD;
&#xD;
          -  Donation of 500 milliliters (mL) or more of blood in the previous 56 days before day 1&#xD;
             of this study&#xD;
&#xD;
        Participants with Normal Hepatic Function:&#xD;
&#xD;
          -  Seated pulse rate less than or equal 50 Beats per Minute (bpm) or more than 100 bpm at&#xD;
             screening&#xD;
&#xD;
          -  Seated blood pressure below 90/60 millimeters of mercury (mmHg) or higher than 140/90&#xD;
             mmHg at screening&#xD;
&#xD;
          -  Presence of significant gastrointestinal, liver, or kidney disease, or any other&#xD;
             conditions known to interfere with the absorption, distribution, metabolism, or&#xD;
             excretion of drugs or known to potentiate or predispose to undesired effects&#xD;
&#xD;
          -  History of significant gastrointestinal, liver or kidney disease that may affect drug&#xD;
             bioavailability&#xD;
&#xD;
          -  Presence of significant cardiovascular, pulmonary, hematologic, neurological,&#xD;
             psychiatric, endocrine, immunologic or dermatologic disease&#xD;
&#xD;
          -  Presence of out-of-range cardiac interval (PR &lt; 110 milliseconds [msec], PR &gt; 220&#xD;
             msec, QRS &lt; 60 msec, QRS &gt;119 msec and QTc &gt; 450 msec for males and &gt; 460 msec for&#xD;
             females) on the screening ECG or other clinically significant ECG abnormalities&#xD;
&#xD;
          -  Maintenance therapy with any drug or significant history of drug dependency or alcohol&#xD;
             abuse (&gt; 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)&#xD;
&#xD;
          -  Positive screening of alcohol and/or drugs of abuse&#xD;
&#xD;
          -  Positive results to Hepatitis B surface Antigen (HBsAG [B] [hepatitis B]) or Hepatitis&#xD;
             C Virus (HCV [C]) tests&#xD;
&#xD;
          -  Any clinically significant illness in the previous 28 days before day 1 of this study&#xD;
&#xD;
          -  Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450&#xD;
             (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin,&#xD;
             fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP&#xD;
             enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and&#xD;
             St John's Wort), in the previous 28 days before day 1 of this study&#xD;
&#xD;
          -  Participants who donated 50 mL or more of blood in the previous 28 days before day 1&#xD;
             of this study&#xD;
&#xD;
        Hepatic Impaired Participants:&#xD;
&#xD;
          -  Seated pulse rate less than 40 bpm or more than 110 bpm at screening&#xD;
&#xD;
          -  Seated blood pressure below 90/50 mmHg or higher than 170/100 mmHg at screening&#xD;
&#xD;
          -  History of hepatic transplant&#xD;
&#xD;
          -  Acute exacerbation of hepatic disease within 14 days of study drug administration&#xD;
&#xD;
          -  History or presence, in the opinion of the Investigator, of significant clinically&#xD;
             unstable respiratory, cardiovascular, pulmonary, renal, hematologic, gastrointestinal,&#xD;
             endocrine, immunologic, dermatologic, neurologic, or psychiatric disease&#xD;
&#xD;
          -  Have poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c &gt;10%&#xD;
&#xD;
          -  Evidence of hepatocellular carcinoma present or acute hepatic disease from infection&#xD;
             or drug toxicity at the time of screening&#xD;
&#xD;
          -  Presence of severe encephalopathy&#xD;
&#xD;
          -  Presence of surgically-created or transjugular intrahepatic portal systemic shunts&#xD;
&#xD;
          -  History of any major surgery within 6 months before Day 1&#xD;
&#xD;
          -  History of bariatric surgery or any other gastrointestinal surgery that may induce&#xD;
             malabsorption&#xD;
&#xD;
          -  Estimated creatinine clearance by Cockcroft-Gault equation &lt; 40 mL/min/1.73 m² at&#xD;
             screening&#xD;
&#xD;
          -  Presence of clinically significant physical, laboratory, or ECG finding that, in the&#xD;
             opinion of the Investigator and/or Sponsor, may interfere with any aspect of study&#xD;
             conduct or interpretation of results&#xD;
&#xD;
          -  Participants with acute, unstable, or untreated significant medical conditions.&#xD;
&#xD;
          -  Positive screening of alcohol and/or drugs of abuse unless results can be explained by&#xD;
             a prescription medication&#xD;
&#xD;
          -  Participants who donated 100 mL or more of blood in the previous 28 days before day 1&#xD;
             of this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orlando Clinical Research Center</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NOCCR</name>
      <address>
        <city>Knoxville</city>
        <state>Kentucky</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altasciences Company Inc./Algorithme Pharma</name>
      <address>
        <city>Mount-Royal</city>
        <state>Quebec</state>
        <zip>H3P 3P1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <results_first_submitted>November 8, 2019</results_first_submitted>
  <results_first_submitted_qc>November 8, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 27, 2019</results_first_posted>
  <last_update_submitted>November 8, 2019</last_update_submitted>
  <last_update_submitted_qc>November 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2019</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>January 9, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03040479/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>October 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03040479/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Male and female adult participants with normal hepatic function, mild and moderate hepatic impairment participated in the study. All participants participated in one treatment period and received a single dose of lasmiditan in the fasting state.Participants confined to the clinic 10 hours prior to dosing until 36 hours after drug administration.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Mild Hepatic Impairment</title>
          <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
        </group>
        <group group_id="P2">
          <title>Moderate Hepatic Impairment</title>
          <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
        </group>
        <group group_id="P3">
          <title>Healthy Participants</title>
          <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All enrolled participants who received at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Mild Hepatic Impairment</title>
          <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
        </group>
        <group group_id="B2">
          <title>Moderate Hepatic Impairment</title>
          <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
        </group>
        <group group_id="B3">
          <title>Healthy Participants</title>
          <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
        </group>
        <group group_id="B4">
          <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="8"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="8"/>
            <count group_id="B4" value="24"/>
          </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="53.9" spread="9.2"/>
                    <measurement group_id="B2" value="59.1" spread="7.3"/>
                    <measurement group_id="B3" value="58.0" spread="6.5"/>
                    <measurement group_id="B4" value="57.0" spread="7.8"/>
                  </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="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="16"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="20"/>
                  </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_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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="22"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" 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>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)</title>
        <description>Maximum observed plasma concentration.</description>
        <time_frame>Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose</time_frame>
        <population>All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Mild Hepatic Impairment</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
          </group>
          <group group_id="O2">
            <title>Moderate Hepatic Impairment</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state</description>
          </group>
          <group group_id="O3">
            <title>Healthy Participants</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)</title>
          <description>Maximum observed plasma concentration.</description>
          <population>All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan 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="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="261" spread="51"/>
                    <measurement group_id="O2" value="294" spread="47"/>
                    <measurement group_id="O3" value="220" spread="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax)</title>
        <description>Time of maximum observed plasma concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value.</description>
        <time_frame>Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose</time_frame>
        <population>All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Mild Hepatic Impairment</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
          </group>
          <group group_id="O2">
            <title>Moderate Hepatic Impairment</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Participants</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax)</title>
          <description>Time of maximum observed plasma concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value.</description>
          <population>All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data.</population>
          <units>hours (hr)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" lower_limit="0.75" upper_limit="3.00"/>
                    <measurement group_id="O2" value="1.38" lower_limit="0.75" upper_limit="2.00"/>
                    <measurement group_id="O3" value="2.52" lower_limit="1.75" upper_limit="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast])</title>
        <description>Cumulative area under the plasma concentration time curve calculated from 0 to TLQC using the linear trapezoidal method, where TLQC represents time of last observed quantifiable plasma concentration.</description>
        <time_frame>Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose</time_frame>
        <population>All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Mild Hepatic Impairment</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
          </group>
          <group group_id="O2">
            <title>Moderate Hepatic Impairment</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Participants</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast])</title>
          <description>Cumulative area under the plasma concentration time curve calculated from 0 to TLQC using the linear trapezoidal method, where TLQC represents time of last observed quantifiable plasma concentration.</description>
          <population>All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data.</population>
          <units>nanogram*hour per milliliter (ng*h/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1750" spread="38"/>
                    <measurement group_id="O2" value="2080" spread="58"/>
                    <measurement group_id="O3" value="1590" spread="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf])</title>
        <description>Area under the plasma concentration time curve extrapolated to infinity, calculated as AUC(0-tlast) + CLQC/λZ, where CLQC is the measured concentration at time TLQC Apparent elimination rate constant and λz is the estimated by linear regression of the terminal linear portion of the log concentration versus time curve.</description>
        <time_frame>Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose</time_frame>
        <population>All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Mild Hepatic Impairment</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
          </group>
          <group group_id="O2">
            <title>Moderate Hepatic Impairment</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Participants</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf])</title>
          <description>Area under the plasma concentration time curve extrapolated to infinity, calculated as AUC(0-tlast) + CLQC/λZ, where CLQC is the measured concentration at time TLQC Apparent elimination rate constant and λz is the estimated by linear regression of the terminal linear portion of the log concentration versus time curve.</description>
          <population>All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data.</population>
          <units>ng*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1790" spread="38"/>
                    <measurement group_id="O2" value="2170" spread="59"/>
                    <measurement group_id="O3" value="1610" spread="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics: Apparent Elimination Rate Constant (λZ)</title>
        <description>Apparent elimination rate constant, estimated by linear regression of the terminal linear portion of the log concentration versus time curve.</description>
        <time_frame>Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose</time_frame>
        <population>All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Mild Hepatic Impairment</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
          </group>
          <group group_id="O2">
            <title>Moderate Hepatic Impairment</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Participants</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Apparent Elimination Rate Constant (λZ)</title>
          <description>Apparent elimination rate constant, estimated by linear regression of the terminal linear portion of the log concentration versus time curve.</description>
          <population>All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data.</population>
          <units>1/hour (1/h)</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="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.121" spread="31"/>
                    <measurement group_id="O2" value="0.089" spread="14"/>
                    <measurement group_id="O3" value="0.136" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics: Terminal Elimination Half-life (T1/2)</title>
        <description>Terminal elimination half-life, calculated as ln(2)/λZ.</description>
        <time_frame>Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose</time_frame>
        <population>All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Mild Hepatic Impairment</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
          </group>
          <group group_id="O2">
            <title>Moderate Hepatic Impairment</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Participants</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Terminal Elimination Half-life (T1/2)</title>
          <description>Terminal elimination half-life, calculated as ln(2)/λZ.</description>
          <population>All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data.</population>
          <units>hours (hr)</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.74" lower_limit="3.57" upper_limit="7.95"/>
                    <measurement group_id="O2" value="7.82" lower_limit="6.58" upper_limit="9.54"/>
                    <measurement group_id="O3" value="5.09" lower_limit="4.56" upper_limit="5.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
        <description>Safety assessed from time of consent through end of study (up to 35 days). A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the Adverse Events module of this record.</description>
        <time_frame>Up To 35 days</time_frame>
        <population>All enrolled participants who received at least one dose of the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Mild Hepatic Impairment</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
          </group>
          <group group_id="O2">
            <title>Moderate Hepatic Impairment</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Participants</title>
            <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
          <description>Safety assessed from time of consent through end of study (up to 35 days). A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the Adverse Events module of this record.</description>
          <population>All enrolled participants who received at least one dose of the 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="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up To 35 days</time_frame>
      <desc>All enrolled participants who received at least one dose of the study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Mild Hepatic Impairment</title>
          <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
        </group>
        <group group_id="E2">
          <title>Moderate Hepatic Impairment</title>
          <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</description>
        </group>
        <group group_id="E3">
          <title>Healthy Participants</title>
          <description>Participants received lasmiditan 200 mg single oral dose in the fasting state.</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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.0</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="3" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </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="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="8"/>
              </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>Details of the study and its results shall not be publicized in any form without prior consent of the Sponsor. Such approval is necessary to prevent premature disclosure of trade secrets and other confidential information.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
      <email>clinicaltrials.gov@lilly.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03040479
org study id: 16881
secondary id: CUD-P9-453
secondary id: H8H-CD-LAHF
secondary id: COL MIG-114
nct id: NCT03040479
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a multicenter, open-label, non-randomized, parallel-group, single dose study. This
      study will enroll up to 24 participants and will include 2 hepatic impaired participant
      groups and one group of control participants with normal hepatic function.
This study will enroll up to 24 participants and will include 2 hepatic impaired participant
      groups and one group of control participants with normal hepatic function. Approximately four
      participants with mild hepatic impairment will be enrolled first (Group 1). To ensure
      participant safety, following dosing of these first four participants, a safety meeting will
      take place to review the safety data prior to dosing additional participants. After safety
      and pharmacokinetic (PK) results from the first four participants have been reviewed, an
      additional four participants with mild hepatic impairment (remainder of Group 1) will be
      enrolled concurrently with the moderate hepatic impairment group (Group 2). Thereafter,
      matched participants with normal hepatic function (Group 3) will be enrolled. All
      participants will participate in one treatment period and will receive a single dose of
      lasmiditan in the fasting state.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: This is a multicenter, open-label, non-randomized, parallel-group, single dose study.
This study will enroll up to 24 participants and will include 2 hepatic impaired participant groups and one group of control participants with normal hepatic function.
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)
time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose
description: Maximum observed plasma concentration.
measure: Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax)
time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose
description: Time of maximum observed plasma concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value.
measure: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast])
time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose
description: Cumulative area under the plasma concentration time curve calculated from 0 to TLQC using the linear trapezoidal method, where TLQC represents time of last observed quantifiable plasma concentration.
measure: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf])
time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose
description: Area under the plasma concentration time curve extrapolated to infinity, calculated as AUC(0-tlast) + CLQC/λZ, where CLQC is the measured concentration at time TLQC Apparent elimination rate constant and λz is the estimated by linear regression of the terminal linear portion of the log concentration versus time curve.
measure: Pharmacokinetics: Apparent Elimination Rate Constant (λZ)
time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose
description: Apparent elimination rate constant, estimated by linear regression of the terminal linear portion of the log concentration versus time curve.
measure: Pharmacokinetics: Terminal Elimination Half-life (T1/2)
time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose
description: Terminal elimination half-life, calculated as ln(2)/λZ.
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Up To 35 days
description: Safety assessed from time of consent through end of study (up to 35 days). A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the Adverse Events module of this record.
arm group label: Mild hepatic impairment
arm group type: Experimental
description: lasmiditan 200 mg single dose
arm group label: Moderate hepatic impairment
arm group type: Experimental
description: lasmiditan 200 mg single dose
arm group label: Healthy participants
arm group type: Experimental
description: lasmiditan 200 mg single dose
intervention type: Drug
intervention name: lasmiditan 200 mg
description: single dose
arm group label: Healthy participants
arm group label: Mild hepatic impairment
arm group label: Moderate hepatic impairment
other name: LY573144
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
facility: 
facility: 
country: Canada
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: 