<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/NCT03009162</url>
  </required_header>
  <id_info>
    <org_study_id>16895</org_study_id>
    <secondary_id>CUD-P4-001</secondary_id>
    <secondary_id>COl MIG-113</secondary_id>
    <secondary_id>H8H-CD-LAHN</secondary_id>
    <nct_id>NCT03009162</nct_id>
  </id_info>
  <brief_title>Study of Oral Lasmiditan in Participants With Normal and Impaired Renal Function</brief_title>
  <official_title>A Phase I, Multicenter, Open-Label, Parallel-Group Adaptive Pharmacokinetic Single Dose Study of Oral Lasmiditan in Subjects With Normal and Impaired Renal Function</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 is a multi-center, open-label, non-randomized, parallel-group, adaptive, single dose&#xD;
      study.&#xD;
&#xD;
      This study will enroll up to 32 participants using an adaptive design that can include up to&#xD;
      3 groups of 8 participants with different degree of renal impairment and one group of 8&#xD;
      control participants with normal renal function.&#xD;
&#xD;
      Screening data will be reviewed to determine participant eligibility. Participants who meet&#xD;
      all inclusion criteria and none of the exclusion criteria will be entered in the study.&#xD;
&#xD;
      First, approximately 16 participants will be enrolled with severe renal impairment and&#xD;
      matched participants with normal renal function. There will be 8 participants in each of the&#xD;
      following groups based on renal function at screening:&#xD;
&#xD;
        -  Group 1: Healthy participants with normal renal function (estimated glomerular&#xD;
           filtration rate [eGFR] ≥ 90 milliliters per minute per 1.73 meters squared&#xD;
           [mL/min/1.73m²])&#xD;
&#xD;
        -  Group 2: Severe renal impairment participants (eGFR &lt; 30 mL/min/1.73m²) Based on safety&#xD;
           and pharmacokinetic (PK) results from participants with severe renal impairment (Group&#xD;
           2), Group 3 (Moderate Renal Impairment) and Group 4 (Mild Renal Impairment) will be&#xD;
           enrolled if substantial change in the exposure of lasmiditan is observed in participants&#xD;
           with severe renal impairment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">June 2, 2017</completion_date>
  <primary_completion_date type="Actual">June 2, 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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>Predose, 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, postdose</time_frame>
    <description>Maximum observed plasma concentration of lasmiditan.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>Predose, 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, postdose</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>Predose, 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, postdose</time_frame>
    <description>Area Under the Concentration Versus Time Curve (AUC) from time zero to tlast (AUC[0- tlast]) of lasmiditan.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf])</measure>
    <time_frame>Predose, 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, postdose</time_frame>
    <description>Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity (AUC[0-inf]) of lasmiditan.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae [0-t])</measure>
    <time_frame>Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose</time_frame>
    <description>Amount excreted in urine (calculated as total lasmiditan concentration multiplied by volume of urine)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: Fraction of Dose Excreted in Urine (fe)</measure>
    <time_frame>Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose</time_frame>
    <description>Fraction of dose excreted in urine (Ae / dose)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: Renal Clearance (CLr)</measure>
    <time_frame>Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose</time_frame>
    <description>Renal Clearance is the volume of blood or plasma that is completely cleared of the drug by the kidneys per unit time. (Ae(0-t)/AUC0-T)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Up To 7 days</time_frame>
    <description>Safety was assessed from time of consent through end of study (up to 7 days). Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Migraine</condition>
  <arm_group>
    <arm_group_label>Renal impaired participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received single 200 milligrams (mg) oral tablet of lasmiditan.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received single 200 mg oral tablet of lasmiditan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lasmiditan</intervention_name>
    <description>200 mg, single oral tablet</description>
    <arm_group_label>Healthy participants</arm_group_label>
    <arm_group_label>Renal impaired participants</arm_group_label>
    <other_name>LY573144</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#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 participant&#xD;
&#xD;
          -  A female participant if of childbearing potential - must be willing to use 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 of child bearing potential must be&#xD;
             willing to use accepted contraceptive regimens.&#xD;
&#xD;
          -  A male participant agrees to refrain from sperm donation from drug administration&#xD;
             until 3 months after the drug administration&#xD;
&#xD;
          -  Participant aged of at least 18 years&#xD;
&#xD;
          -  Participant with a body mass index (BMI) ≥18.50 kilogram per meter squared (kg/m²) and&#xD;
             &lt; 42.00 kg/m²&#xD;
&#xD;
          -  Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes&#xD;
             or less per day for at least 3 months before Day 1 of this study. An ex smoker is&#xD;
             defined as someone who completely stopped smoking for at least 6 months before Day 1&#xD;
             of this study&#xD;
&#xD;
          -  Willingness to adhere to the protocol requirements as evidenced by the informed&#xD;
             consent form (ICF) duly read, signed and dated by the participant&#xD;
&#xD;
        Participants with Normal Renal 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, electrocardiogram [ECG], and&#xD;
             urinalysis)&#xD;
&#xD;
          -  For each gender, have to match by age (± 10 years) and weight (± 20%) to the pooled&#xD;
             mean values of participants with severe renal impairment&#xD;
&#xD;
          -  Have an eGFR ≥ 90 mL/min/1.73m² calculated using Modification of Diet in Renal Disease&#xD;
             (MDRD) equation at screening&#xD;
&#xD;
        Renal Impaired Participants:&#xD;
&#xD;
          -  Considered clinically stable in the opinion of the Investigator&#xD;
&#xD;
          -  Presence of mild renal impairment (eGFR 60-89 mL/min/1.73m²), moderate renal&#xD;
             impairment (eGFR 30-59 mL/min/1.73m²), or severe renal impairment (eGFR &lt; 30&#xD;
             mL/min/1.73m²) calculated using MDRD equation 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 6&#xD;
             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 antigen/antibody (HIV Ag/Ab) Combo,&#xD;
             Hepatitis B surface antigen (HBsAG (B) (hepatitis B) or Hepatitis C Virus (HCV [C])&#xD;
             tests&#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;
          -  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;
          -  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;
          -  Participants who donated 50 mL or more of blood in the previous 28 days before Day 1&#xD;
             of this study&#xD;
&#xD;
          -  Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical&#xD;
             studies, etc.) in the previous 56 days before Day 1 of this study&#xD;
&#xD;
        Participants with Normal Renal Function:&#xD;
&#xD;
          -  Seated pulse rate less than or equal 40 Beats per Minute (bpm) or more than - Seated&#xD;
             blood pressure below 90/60 millimeters of mercury (mmHg) or higher than 140/90 mmHg at&#xD;
             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, including but not limited to cholecystectomy&#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 correct QT interval (QTc) &gt; 450 msec for males&#xD;
             and &gt; 460 msec for females) on the screening ECG or other clinically significant ECG&#xD;
             abnormalities&#xD;
&#xD;
          -  Positive screening of alcohol and/or drugs of abuse&#xD;
&#xD;
          -  Any clinically significant illness in the previous 28 days before Day 1 of this study&#xD;
&#xD;
        Renal Impaired Participants:&#xD;
&#xD;
          -  Seated pulse rate less than 50 bpm or more than 110 bpm at screening&#xD;
&#xD;
          -  Seated blood pressure below 90/50 mmHg or higher than 180/110 mmHg at screening&#xD;
&#xD;
          -  Currently undergoing any method of dialysis&#xD;
&#xD;
          -  History of renal transplant&#xD;
&#xD;
          -  History or presence, in the opinion of the Investigator, of significant clinically&#xD;
             unstable respiratory, cardiovascular, pulmonary, hepatic, hematologic,&#xD;
             gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric&#xD;
             disease,&#xD;
&#xD;
          -  Have poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c &gt;10%&#xD;
&#xD;
          -  Require immunosuppressive medications for treatment of immune-mediated renal disease&#xD;
             or kidney transplant recipients&#xD;
&#xD;
          -  Evidence of renal carcinoma present at the time of screening&#xD;
&#xD;
          -  Have relevant clinical laboratory abnormalities, including any elevation of alanine&#xD;
             aminotransferase (ALT), aspartate aminotransferase (AST), or bilirubin at screening.&#xD;
             If the investigator concludes that there is no safety risk for participants with&#xD;
             isolated laboratory abnormalities (eg, those that do not reflect end-organ&#xD;
             dysfunction; for example, elevated bilirubin in Gilbert's participants) to participate&#xD;
             in the study, such cases need to be discussed and approved by the sponsor's medical&#xD;
             monitor prior to study enrollment&#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;
             Participants requiring treatment for renal impairment or other chronic disease (eg,&#xD;
             well-controlled diabetes, hypertension) must be on a stable treatment plan (medicines,&#xD;
             doses, and regimens) for at least 2 weeks (except insulin) prior to Day 1 and during&#xD;
             the entire study. Small adjustments in the dosages of some concomitant medications may&#xD;
             be permitted during the study, and will be discussed on a case-by-case basis. In all&#xD;
             cases, the participants' treatment history must be reviewed and their enrollment must&#xD;
             be agreed to by both the investigator and the sponsor's medical monitor&#xD;
&#xD;
          -  Positive screening of alcohol and/or drugs of abuse unless results can be explained by&#xD;
             a prescription medication&#xD;
&#xD;
          -  Concurrent use of medications known to affect the elimination of serum creatinine (eg,&#xD;
             trimethoprim/sulfamethoxazole [Bactrim®] or cimetidine [Tagamet®]) and competitors of&#xD;
             renal tubular secretion (eg, probenecid) within 30 days prior to the first dose of&#xD;
             study drug or anticipated need for these therapies through the last pharmacokinetic&#xD;
             (PK) sample&#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>CIUSSS de l'est-de-l'île-de-Montréal - installation Hôpital Maisonneuve-Rosemont</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3P3P1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Algorithme Pharma</name>
      <address>
        <city>Mount Royal</city>
        <state>Quebec</state>
        <zip>H3P3P1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <results_first_submitted>November 8, 2019</results_first_submitted>
  <results_first_submitted_qc>November 27, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 2, 2019</results_first_posted>
  <last_update_submitted>November 27, 2019</last_update_submitted>
  <last_update_submitted_qc>November 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lasmiditan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03009162/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>February 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03009162/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Healthy Participants</title>
          <description>Participants received single 200 milligrams (mg) oral dose of lasmiditan.</description>
        </group>
        <group group_id="P2">
          <title>Renal Impaired Participants</title>
          <description>Participants received single 200 mg oral dose of lasmiditan.</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_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_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" 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_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>Healthy Participants</title>
          <description>Participants received single 200 milligrams (mg) oral dose of lasmiditan.</description>
        </group>
        <group group_id="B2">
          <title>Renal Impaired Participants</title>
          <description>Participants received single 200 mg oral dose of lasmiditan.</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="8"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="16"/>
          </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="45.4" spread="12.3"/>
                    <measurement group_id="B2" value="51.8" spread="15.6"/>
                    <measurement group_id="B3" value="48.6" spread="14.0"/>
                  </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="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </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="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)</title>
        <description>Maximum observed plasma concentration of lasmiditan.</description>
        <time_frame>Predose, 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, postdose</time_frame>
        <population>All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetics (PK) data.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Participants</title>
            <description>Participants received single 200 mg oral dose of lasmiditan.</description>
          </group>
          <group group_id="O2">
            <title>Renal Impaired Participants</title>
            <description>Participants received single 200 mg oral dose of lasmiditan.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)</title>
          <description>Maximum observed plasma concentration of lasmiditan.</description>
          <population>All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetics (PK) data.</population>
          <units>nanogram per milliliter (ng/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="259" spread="44"/>
                    <measurement group_id="O2" value="293" spread="35"/>
                  </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>Predose, 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, postdose</time_frame>
        <population>All enrolled participants who received at least one dose of study drug and have evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Participants</title>
            <description>Participants received single 200 mg oral dose of lasmiditan.</description>
          </group>
          <group group_id="O2">
            <title>Renal Impaired Participants</title>
            <description>Participants received single 200 mg oral dose of lasmiditan.</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 study drug and have evaluable PK data.</population>
          <units>hours (h)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.50" lower_limit="1.00" upper_limit="3.00"/>
                    <measurement group_id="O2" value="1.78" lower_limit="0.75" upper_limit="3.00"/>
                  </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>Area Under the Concentration Versus Time Curve (AUC) from time zero to tlast (AUC[0- tlast]) of lasmiditan.</description>
        <time_frame>Predose, 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, postdose</time_frame>
        <population>All enrolled participants who received at least one dose of study drug and have evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Participants</title>
            <description>Participants received single 200 mg oral dose of lasmiditan.</description>
          </group>
          <group group_id="O2">
            <title>Renal Impaired Participants</title>
            <description>Participants received single 200 mg oral dose of lasmiditan.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast])</title>
          <description>Area Under the Concentration Versus Time Curve (AUC) from time zero to tlast (AUC[0- tlast]) of lasmiditan.</description>
          <population>All enrolled participants who received at least one dose of study drug and have evaluable PK data.</population>
          <units>nanogram*hour per milliliter (ng*h/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1580" spread="44"/>
                    <measurement group_id="O2" value="1870" spread="32"/>
                  </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 Concentration Versus Time Curve (AUC) from time zero to infinity (AUC[0-inf]) of lasmiditan.</description>
        <time_frame>Predose, 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, postdose</time_frame>
        <population>All enrolled participants who received at least one dose of study drug and have evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Participants</title>
            <description>Participants received single 200 mg oral dose of lasmiditan.</description>
          </group>
          <group group_id="O2">
            <title>Renal Impaired Participants</title>
            <description>Participants received single 200 mg oral dose of lasmiditan.</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 Concentration Versus Time Curve (AUC) from time zero to infinity (AUC[0-inf]) of lasmiditan.</description>
          <population>All enrolled participants who received at least one dose of study drug and have evaluable PK data.</population>
          <units>ng*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1600" spread="44"/>
                    <measurement group_id="O2" value="1890" spread="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics: Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae [0-t])</title>
        <description>Amount excreted in urine (calculated as total lasmiditan concentration multiplied by volume of urine)</description>
        <time_frame>Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose</time_frame>
        <population>All enrolled participants who received at least one dose of study drug and have evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Participants</title>
            <description>Participants received single 200 mg oral dose of lasmiditan.</description>
          </group>
          <group group_id="O2">
            <title>Renal Impaired Participants</title>
            <description>Participants received single 200 mg oral dose of lasmiditan.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae [0-t])</title>
          <description>Amount excreted in urine (calculated as total lasmiditan concentration multiplied by volume of urine)</description>
          <population>All enrolled participants who received at least one dose of study drug and have evaluable PK data.</population>
          <units>milligrams (mg)</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.64" spread="36"/>
                    <measurement group_id="O2" value="1.85" spread="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics: Fraction of Dose Excreted in Urine (fe)</title>
        <description>Fraction of dose excreted in urine (Ae / dose)</description>
        <time_frame>Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose</time_frame>
        <population>All enrolled participants who received at least one dose of study drug and have evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Participants</title>
            <description>Participants received single 200 mg oral dose of lasmiditan.</description>
          </group>
          <group group_id="O2">
            <title>Renal Impaired Participants</title>
            <description>Participants received single 200 mg oral dose of lasmiditan.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Fraction of Dose Excreted in Urine (fe)</title>
          <description>Fraction of dose excreted in urine (Ae / dose)</description>
          <population>All enrolled participants who received at least one dose of study drug and have evaluable PK data.</population>
          <units>Percentage</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.32" spread="36"/>
                    <measurement group_id="O2" value="0.93" spread="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics: Renal Clearance (CLr)</title>
        <description>Renal Clearance is the volume of blood or plasma that is completely cleared of the drug by the kidneys per unit time. (Ae(0-t)/AUC0-T)</description>
        <time_frame>Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose</time_frame>
        <population>All enrolled participants who received at least one dose of study drug and have evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Participants</title>
            <description>Participants received single 200 mg oral dose of lasmiditan.</description>
          </group>
          <group group_id="O2">
            <title>Renal Impaired Participants</title>
            <description>Participants received single 200 mg oral dose of lasmiditan.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Renal Clearance (CLr)</title>
          <description>Renal Clearance is the volume of blood or plasma that is completely cleared of the drug by the kidneys per unit time. (Ae(0-t)/AUC0-T)</description>
          <population>All enrolled participants who received at least one dose of study drug and have evaluable PK data.</population>
          <units>Liters/hour (L/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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.93" spread="28"/>
                    <measurement group_id="O2" value="0.992" spread="42"/>
                  </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 was assessed from time of consent through end of study (up to 7 days). Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.</description>
        <time_frame>Up To 7 days</time_frame>
        <population>All enrolled participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Participants</title>
            <description>Participants received single 200 mg oral dose of lasmiditan.</description>
          </group>
          <group group_id="O2">
            <title>Renal Impaired Participants</title>
            <description>Participants received single 200 mg oral dose of lasmiditan.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
          <description>Safety was assessed from time of consent through end of study (up to 7 days). Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.</description>
          <population>All enrolled participants who received at least one dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Other AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up To 7 days</time_frame>
      <desc>All enrolled participants who received at least one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Healthy Participants</title>
          <description>Participants received single 200 mg oral dose of lasmiditan.</description>
        </group>
        <group group_id="E2">
          <title>Renal Impaired Participants</title>
          <description>Participants received single 200 mg oral dose of lasmiditan.</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"/>
              </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"/>
              </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="6" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Feeling abnormal</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"/>
              </event>
              <event>
                <sub_title>Vessel puncture site bruise</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"/>
              </event>
              <event>
                <sub_title>Vessel puncture site erythema</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"/>
              </event>
              <event>
                <sub_title>Vessel puncture site pain</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"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Foreign body in respiratory tract</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"/>
              </event>
              <event>
                <sub_title>Procedural anxiety</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"/>
              </event>
              <event>
                <sub_title>Scratch</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"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Lethargy</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"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" 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"/>
              </event>
              <event>
                <sub_title>Tremor</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"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" 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/NCT03009162
org study id: 16895
secondary id: CUD-P4-001
secondary id: COl MIG-113
secondary id: H8H-CD-LAHN
nct id: NCT03009162
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a multi-center, open-label, non-randomized, parallel-group, adaptive, single dose
      study.

      This study will enroll up to 32 participants using an adaptive design that can include up to
      3 groups of 8 participants with different degree of renal impairment and one group of 8
      control participants with normal renal function.

      Screening data will be reviewed to determine participant eligibility. Participants who meet
      all inclusion criteria and none of the exclusion criteria will be entered in the study.

      First, approximately 16 participants will be enrolled with severe renal impairment and
      matched participants with normal renal function. There will be 8 participants in each of the
      following groups based on renal function at screening:

        -  Group 1: Healthy participants with normal renal function (estimated glomerular
           filtration rate [eGFR] ≥ 90 milliliters per minute per 1.73 meters squared
           [mL/min/1.73m²])

        -  Group 2: Severe renal impairment participants (eGFR < 30 mL/min/1.73m²) Based on safety
           and pharmacokinetic (PK) results from participants with severe renal impairment (Group
           2), Group 3 (Moderate Renal Impairment) and Group 4 (Mild Renal Impairment) will be
           enrolled if substantial change in the exposure of lasmiditan is observed in participants
           with severe renal impairment.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)
time frame: Predose, 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, postdose
description: Maximum observed plasma concentration of lasmiditan.
measure: Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax)
time frame: Predose, 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, postdose
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: Predose, 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, postdose
description: Area Under the Concentration Versus Time Curve (AUC) from time zero to tlast (AUC[0- tlast]) of lasmiditan.
measure: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf])
time frame: Predose, 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, postdose
description: Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity (AUC[0-inf]) of lasmiditan.
measure: Pharmacokinetics: Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae [0-t])
time frame: Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose
description: Amount excreted in urine (calculated as total lasmiditan concentration multiplied by volume of urine)
measure: Pharmacokinetics: Fraction of Dose Excreted in Urine (fe)
time frame: Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose
description: Fraction of dose excreted in urine (Ae / dose)
measure: Pharmacokinetics: Renal Clearance (CLr)
time frame: Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose
description: Renal Clearance is the volume of blood or plasma that is completely cleared of the drug by the kidneys per unit time. (Ae(0-t)/AUC0-T)
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Up To 7 days
description: Safety was assessed from time of consent through end of study (up to 7 days). Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.
arm group label: Renal impaired participants
arm group type: Experimental
description: Participants received single 200 milligrams (mg) oral tablet of lasmiditan.
arm group label: Healthy participants
arm group type: Experimental
description: Participants received single 200 mg oral tablet of lasmiditan.
intervention type: Drug
intervention name: Lasmiditan
description: 200 mg, single oral tablet
arm group label: Healthy participants
arm group label: Renal impaired participants
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: 
country: Canada
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Lasmiditan
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 