<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/NCT03040362</url>
  </required_header>
  <id_info>
    <org_study_id>16884</org_study_id>
    <secondary_id>H8H-CD-LAHH</secondary_id>
    <secondary_id>COL MIG-110</secondary_id>
    <nct_id>NCT03040362</nct_id>
  </id_info>
  <brief_title>Absorption, Metabolism and Excretion of [14C]-Lasmiditan - Single Oral Dose Administration</brief_title>
  <official_title>A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-Lasmiditan Following Single Oral Dose Administration in Healthy Male and Female Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CoLucid Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be an open-label, nonrandomized, absorption, metabolism, and excretion study&#xD;
      of [14C]-lasmiditan administered as a 200-milligrams (mg) (approximately 100&#xD;
      microcuries[µCi]) oral solution to 8 healthy males and females, following at least a 10 hour&#xD;
      fast from food to assess the pharmacokinetics (PK), metabolism, and routes and extent of&#xD;
      elimination of a single oral dose of 200 mg (approximately 100 µCi) [14C] lasmiditan in&#xD;
      healthy males and females.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 20, 2017</start_date>
  <completion_date type="Actual">May 6, 2017</completion_date>
  <primary_completion_date type="Actual">May 6, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group 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>Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours post-dose</time_frame>
    <description>Maximum observed concentration based on plasma concentrations of lasmiditan.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours pos-tdose</time_frame>
    <description>Time to maximum concentration based on plasma concentrations of lasmiditan.</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, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours post-dose</time_frame>
    <description>Area under concentration time curve (AUC) from Hour 0 to the last measurable concentration based on plasma concentrations of lasmiditan.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC Time Zero to Infinity (AUC0-∞) Blood/Plasma Ratio</measure>
    <time_frame>Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours post-dose</time_frame>
    <description>AUC time zero to infinity (0-∞) of total radioactivity in blood/AUC0-∞ of total radioactivity in plasma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC Time Zero to Infinity (AUC0-∞) Plasma Lasmiditan/Total Radioactivity Ratio</measure>
    <time_frame>Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours pos-tdose</time_frame>
    <description>AUC time zero to infinity (0-∞) of lasmiditan in plasma/AUC0-∞ of total radioactivity in plasma.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics - Cumulative Amount of Lasmiditan and Its Metabolites Excreted in Urine</measure>
    <time_frame>Pre-dose (-12 to 0 hours) and intervals: 0 to 6, 6 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, and 168 to 192 hours post-dose</time_frame>
    <description>Amount of Lasmiditan and its metabolites (M3, M7, M8, (S,R)-M18, and (S,S)-M18) excreted in urine (Aeu) over sampling interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Lasmiditan Recovered in Urine, Relative to Dose Administered</measure>
    <time_frame>Pre-dose (-12 to 0 hours) and intervals: 0 to 6, 6 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, and 168 to 192 hours post-dose</time_frame>
    <description>Percentage of lasmiditan recovered in urine (%UR), relative to dose administered calculated as %UR = 100 (amount of lasmiditan excreted in urine over a sampling interval (Aeu)/dose).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Clearance (CLR)</measure>
    <time_frame>Pre-dose (-12 to 0 hours) and intervals: 0 to 6, 6 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, and 168 to 192 hours post-dose</time_frame>
    <description>Renal clearance is the volume of plasma completely cleared of lasmiditan by the kidneys per unit time and calculated as CLR = Aeu/AUC0-x (where Aeu = amount of lasmiditan excreted in urine over a sampling interval; x is the last interval collected; for lasmiditan only).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to 49 days</time_frame>
    <description>Safety assessed from time of consent through end of study (up to 49 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>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>[14C]-lasmiditan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>[14C]-lasmiditan administered as a 200 mg (approximately 100 µCi) oral solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[14C]-lasmiditan</intervention_name>
    <description>[14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution</description>
    <arm_group_label>[14C]-lasmiditan</arm_group_label>
    <other_name>LY573144</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females, between 18 and 60 years of age, inclusive, at Screening&#xD;
&#xD;
          -  Have a body mass index range of 18.5 to 32.0 kilograms per meter squared (kg/m²),&#xD;
             inclusive, at Screening&#xD;
&#xD;
          -  In good health, determined by no clinically significant findings from medical history,&#xD;
             12 lead electrocardiogram (ECG), and vital signs measurements at Screening or Check-in&#xD;
             (Day 1) as determined by the Investigator (or designee)&#xD;
&#xD;
          -  Clinical laboratory evaluations (including clinical chemistry panel [fasted at least&#xD;
             10 hours], hematology/complete blood count [CBC], and urinalysis [UA]; within the&#xD;
             reference range for the test laboratory at Screening and Check-in, unless deemed not&#xD;
             clinically significant by the Investigator (or designee)&#xD;
&#xD;
          -  Negative test for selected drugs of abuse at Screening (does not include alcohol) and&#xD;
             at Check-in (does include alcohol)&#xD;
&#xD;
          -  Negative hepatitis panel (including hepatitis B surface antigen and hepatitis C virus&#xD;
             antibody and negative human immunodeficiency virus (HIV) antibody screens&#xD;
&#xD;
          -  Females must be nonpregnant, nonlactating, and either postmenopausal (defined as no&#xD;
             menstrual period for at least 12 months and confirmed by a serum follicle-stimulating&#xD;
             hormone (FSH) level of ≥40 milli-international units (mIU/mL), surgically sterile&#xD;
             (e.g., bilateral oophorectomy, salpingectomy, and/or hysterectomy) for at least 90&#xD;
             days prior to Screening, or must have undergone bilateral tubal ligation and agree to&#xD;
             use effective contraception. For all females, the pregnancy test results must be&#xD;
             negative at Screening and Check-in&#xD;
&#xD;
          -  Males will be surgically sterile for at least 90 days prior to Screening or when&#xD;
             sexually-active with female partners of child-bearing potential will agree to use&#xD;
             contraception from Check-in until 90 days following Discharge. Male participants must&#xD;
             also be willing to refrain from donating sperm from Check-in until 90 days following&#xD;
             Discharge&#xD;
&#xD;
          -  Able to comprehend and willing to sign an informed consent form (ICF)&#xD;
&#xD;
          -  A minimum of 1 to 2 bowel movements per day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant history or clinical manifestation of any metabolic, allergic, infectious,&#xD;
             dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,&#xD;
             gastrointestinal, neurological, or psychiatric disorder (as determined by the&#xD;
             Investigator [or designee]) prior to Check-in&#xD;
&#xD;
          -  History of significant hypersensitivity, intolerance, or allergy to any drug compound,&#xD;
             food, or other substance, unless approved by the Investigator (or designee) prior to&#xD;
             Check-in&#xD;
&#xD;
          -  History of stomach or intestinal surgery or resection that could alter absorption or&#xD;
             excretion of orally administered drugs prior to Check-in, except that cholecystectomy,&#xD;
             appendectomy, and hernia repair will be allowed if it was not associated with&#xD;
             complications&#xD;
&#xD;
          -  History or presence of an abnormal ECG that, in the Investigator's (or designee's)&#xD;
             opinion, is clinically significant at Screening or Check-in&#xD;
&#xD;
          -  History of orthostatic hypotension with or without syncope&#xD;
&#xD;
          -  A sustained seated systolic blood pressure &gt;150 millimeters of mercury (mmHg) or &lt;90&#xD;
             mmHg or a diastolic blood pressure &gt;90 mmHg or &lt;50 mmHg at Screening or Check in.&#xD;
             Blood pressure may be retested twice at intervals of 5 minutes. The out of range blood&#xD;
             pressure values will be considered sustained if either the systolic or diastolic blood&#xD;
             pressures are outside the stated limits after these 3 assessments&#xD;
&#xD;
          -  History of alcoholism or drug addiction within 1 year prior to Check-in&#xD;
&#xD;
          -  Use of any tobacco- or nicotine-containing products (including but not limited to&#xD;
             cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine&#xD;
             lozenges, or nicotine gum) within 6 months prior to Check-in, or positive cotinine&#xD;
             screen at Screening or Check-in&#xD;
&#xD;
          -  Participation in more than 1 other radiolabeled investigational study drug trial&#xD;
             within 12 months prior to Check-in. The previous radiolabeled study drug must have&#xD;
             been received more than 6 months prior to Check-in for this study and the total&#xD;
             exposure from this study and the previous study will be within the recommended levels&#xD;
             considered safe, per United States (US) Title 21 Code of Federal Regulations (CFR)&#xD;
             361.1 (e.g., less than 5,000 millirem [mrem] whole body annual exposure)&#xD;
&#xD;
          -  Exposure to significant radiation (e.g., serial x-ray or computed tomography scans,&#xD;
             barium meal, current employment in a job requiring radiation exposure monitoring)&#xD;
             within 12 months prior to Check-in&#xD;
&#xD;
          -  Participation in any other investigational study drug trial in which receipt of an&#xD;
             investigational study drug occurred within 5 half-lives (if known) or 30 days prior to&#xD;
             Check-in, whichever is longer&#xD;
&#xD;
          -  Use of any prescription medications/products within 14 days prior to Check-in, unless&#xD;
             deemed acceptable by the Investigator (or designee)&#xD;
&#xD;
          -  Use of any over-the-counter, nonprescription preparations (including vitamins,&#xD;
             minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior&#xD;
             to Check-in, unless deemed acceptable by the Investigator (or designee)&#xD;
&#xD;
          -  Poor peripheral venous access prior to Check-in&#xD;
&#xD;
          -  Donation of whole blood from 56 days prior to Screening through Discharge, inclusive,&#xD;
             or of plasma from 30 days prior to Screening through Discharge, inclusive&#xD;
&#xD;
          -  Receipt of blood products within 2 months prior to Check-in&#xD;
&#xD;
          -  Participant is at imminent risk of suicide (positive response to question 4 or 5 on&#xD;
             the baseline Columbia-Suicide Severity Rating Scale (C-SSRS) or had a suicide attempt&#xD;
             within 6 months prior to Screening&#xD;
&#xD;
          -  Any acute or chronic condition that, in the opinion of the Investigator (or designee),&#xD;
             would limit the particpant's ability to complete or participate in this clinical study&#xD;
&#xD;
          -  Any other unspecified reason that, in the opinion of the Investigator (or designee) or&#xD;
             Sponsor, makes the participant unsuitable for enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance Clinical Research Unit</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <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>December 20, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 10, 2020</results_first_posted>
  <last_update_submitted>December 20, 2019</last_update_submitted>
  <last_update_submitted_qc>December 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lasmiditan</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 23, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03040362/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>June 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03040362/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants were preceded by an overnight fast (at least 10 hours) from food (not including water) before receiving a dose of [14C]-lasmiditan.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>[14C]-Lasmiditan</title>
          <description>Participants were administered a single oral dose of radiolabeled [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution on Day 1.</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_list>
            </milestone>
            <milestone>
              <title>Received at Least 1dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" 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>[14C]-Lasmiditan</title>
          <description>Participants were administered a single oral dose of radiolabeled [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution on Day 1.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
          </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="39" spread="15.2"/>
                  </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="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </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 concentration based on plasma concentrations of lasmiditan.</description>
        <time_frame>Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours post-dose</time_frame>
        <population>All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Lasmiditan</title>
            <description>Participants were administered a single oral dose of radiolabeled [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)</title>
          <description>Maximum observed concentration based on plasma concentrations of lasmiditan.</description>
          <population>All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="299" spread="36"/>
                  </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 to maximum concentration based on plasma concentrations of lasmiditan.</description>
        <time_frame>Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours pos-tdose</time_frame>
        <population>All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Lasmiditan</title>
            <description>Participants were administered a single oral dose of radiolabeled [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax)</title>
          <description>Time to maximum concentration based on plasma concentrations of lasmiditan.</description>
          <population>All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.02" lower_limit="2.00" 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 concentration time curve (AUC) from Hour 0 to the last measurable concentration based on plasma concentrations of lasmiditan.</description>
        <time_frame>Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours post-dose</time_frame>
        <population>All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Lasmiditan</title>
            <description>Participants were administered a single oral dose of radiolabeled [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution on Day 1.</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 concentration time curve (AUC) from Hour 0 to the last measurable concentration based on plasma concentrations of lasmiditan.</description>
          <population>All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2100" spread="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC Time Zero to Infinity (AUC0-∞) Blood/Plasma Ratio</title>
        <description>AUC time zero to infinity (0-∞) of total radioactivity in blood/AUC0-∞ of total radioactivity in plasma.</description>
        <time_frame>Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours post-dose</time_frame>
        <population>All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Lasmiditan</title>
            <description>Participants were administered a single oral dose of radiolabeled [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC Time Zero to Infinity (AUC0-∞) Blood/Plasma Ratio</title>
          <description>AUC time zero to infinity (0-∞) of total radioactivity in blood/AUC0-∞ of total radioactivity in plasma.</description>
          <population>All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.</population>
          <units>Ratio</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.948" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC Time Zero to Infinity (AUC0-∞) Plasma Lasmiditan/Total Radioactivity Ratio</title>
        <description>AUC time zero to infinity (0-∞) of lasmiditan in plasma/AUC0-∞ of total radioactivity in plasma.</description>
        <time_frame>Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours pos-tdose</time_frame>
        <population>All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Lasmiditan</title>
            <description>Participants were administered a single oral dose of radiolabeled [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC Time Zero to Infinity (AUC0-∞) Plasma Lasmiditan/Total Radioactivity Ratio</title>
          <description>AUC time zero to infinity (0-∞) of lasmiditan in plasma/AUC0-∞ of total radioactivity in plasma.</description>
          <population>All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.</population>
          <units>Ratio</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.131" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics - Cumulative Amount of Lasmiditan and Its Metabolites Excreted in Urine</title>
        <description>Amount of Lasmiditan and its metabolites (M3, M7, M8, (S,R)-M18, and (S,S)-M18) excreted in urine (Aeu) over sampling interval.</description>
        <time_frame>Pre-dose (-12 to 0 hours) and intervals: 0 to 6, 6 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, and 168 to 192 hours post-dose</time_frame>
        <population>All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Lasmiditan</title>
            <description>Participants were administered a single oral dose of radiolabeled [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics - Cumulative Amount of Lasmiditan and Its Metabolites Excreted in Urine</title>
          <description>Amount of Lasmiditan and its metabolites (M3, M7, M8, (S,R)-M18, and (S,S)-M18) excreted in urine (Aeu) over sampling interval.</description>
          <population>All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.</population>
          <units>milligram (mg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lasmiditan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.81" spread="1.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.62" spread="0.506"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00224" spread="0.000902"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="132" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>(S,R)-M18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.85" spread="0.534"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>(S,S)-M18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.445" spread="0.127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Lasmiditan Recovered in Urine, Relative to Dose Administered</title>
        <description>Percentage of lasmiditan recovered in urine (%UR), relative to dose administered calculated as %UR = 100 (amount of lasmiditan excreted in urine over a sampling interval (Aeu)/dose).</description>
        <time_frame>Pre-dose (-12 to 0 hours) and intervals: 0 to 6, 6 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, and 168 to 192 hours post-dose</time_frame>
        <population>All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Lasmiditan</title>
            <description>Participants were administered a single oral dose of radiolabeled [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Lasmiditan Recovered in Urine, Relative to Dose Administered</title>
          <description>Percentage of lasmiditan recovered in urine (%UR), relative to dose administered calculated as %UR = 100 (amount of lasmiditan excreted in urine over a sampling interval (Aeu)/dose).</description>
          <population>All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.</population>
          <units>% of lasmiditan dose</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.91" spread="0.561"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Renal Clearance (CLR)</title>
        <description>Renal clearance is the volume of plasma completely cleared of lasmiditan by the kidneys per unit time and calculated as CLR = Aeu/AUC0-x (where Aeu = amount of lasmiditan excreted in urine over a sampling interval; x is the last interval collected; for lasmiditan only).</description>
        <time_frame>Pre-dose (-12 to 0 hours) and intervals: 0 to 6, 6 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, and 168 to 192 hours post-dose</time_frame>
        <population>All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Lasmiditan</title>
            <description>Participants were administered a single oral dose of radiolabeled [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Renal Clearance (CLR)</title>
          <description>Renal clearance is the volume of plasma completely cleared of lasmiditan by the kidneys per unit time and calculated as CLR = Aeu/AUC0-x (where Aeu = amount of lasmiditan excreted in urine over a sampling interval; x is the last interval collected; for lasmiditan only).</description>
          <population>All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.</population>
          <units>liter per hour (L/hr)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.89" spread="1.12"/>
                  </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 49 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 49 days</time_frame>
        <population>All enrolled participants who received at least one dose of the study drug and had at least 1 post-dose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Lasmiditan</title>
            <description>Participants were administered a single oral dose of radiolabeled [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution on Day 1.</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 49 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 and had at least 1 post-dose safety assessment.</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adverse Events (AEs)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious Adverse Events (SAEs)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up To 49 Days</time_frame>
      <desc>All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment.</desc>
      <group_list>
        <group group_id="E1">
          <title>[14C]-Lasmiditan</title>
          <description>Participants were administered a single oral dose of radiolabeled [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution on Day 1.</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"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" 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 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>External ear pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" 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"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia oral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" 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="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Feeling drunk</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post procedural contusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Procedural site reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" 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="2" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Sensory disturbance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Euphoric mood</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" 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/NCT03040362
org study id: 16884
secondary id: H8H-CD-LAHH
secondary id: COL MIG-110
nct id: NCT03040362
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will be an open-label, nonrandomized, absorption, metabolism, and excretion study
      of [14C]-lasmiditan administered as a 200-milligrams (mg) (approximately 100
      microcuries[µCi]) oral solution to 8 healthy males and females, following at least a 10 hour
      fast from food to assess the pharmacokinetics (PK), metabolism, and routes and extent of
      elimination of a single oral dose of 200 mg (approximately 100 µCi) [14C] lasmiditan in
      healthy males and females.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)
time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours post-dose
description: Maximum observed concentration based on plasma concentrations of lasmiditan.
measure: Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax)
time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours pos-tdose
description: Time to maximum concentration based on plasma concentrations of lasmiditan.
measure: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast])
time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours post-dose
description: Area under concentration time curve (AUC) from Hour 0 to the last measurable concentration based on plasma concentrations of lasmiditan.
measure: AUC Time Zero to Infinity (AUC0-∞) Blood/Plasma Ratio
time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours post-dose
description: AUC time zero to infinity (0-∞) of total radioactivity in blood/AUC0-∞ of total radioactivity in plasma.
measure: AUC Time Zero to Infinity (AUC0-∞) Plasma Lasmiditan/Total Radioactivity Ratio
time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours pos-tdose
description: AUC time zero to infinity (0-∞) of lasmiditan in plasma/AUC0-∞ of total radioactivity in plasma.
measure: Pharmacokinetics - Cumulative Amount of Lasmiditan and Its Metabolites Excreted in Urine
time frame: Pre-dose (-12 to 0 hours) and intervals: 0 to 6, 6 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, and 168 to 192 hours post-dose
description: Amount of Lasmiditan and its metabolites (M3, M7, M8, (S,R)-M18, and (S,S)-M18) excreted in urine (Aeu) over sampling interval.
measure: Percentage of Lasmiditan Recovered in Urine, Relative to Dose Administered
time frame: Pre-dose (-12 to 0 hours) and intervals: 0 to 6, 6 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, and 168 to 192 hours post-dose
description: Percentage of lasmiditan recovered in urine (%UR), relative to dose administered calculated as %UR = 100 (amount of lasmiditan excreted in urine over a sampling interval (Aeu)/dose).
measure: Renal Clearance (CLR)
time frame: Pre-dose (-12 to 0 hours) and intervals: 0 to 6, 6 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, and 168 to 192 hours post-dose
description: Renal clearance is the volume of plasma completely cleared of lasmiditan by the kidneys per unit time and calculated as CLR = Aeu/AUC0-x (where Aeu = amount of lasmiditan excreted in urine over a sampling interval; x is the last interval collected; for lasmiditan only).
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Up to 49 days
description: Safety assessed from time of consent through end of study (up to 49 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: [14C]-lasmiditan
arm group type: Experimental
description: [14C]-lasmiditan administered as a 200 mg (approximately 100 µCi) oral solution
intervention type: Drug
intervention name: [14C]-lasmiditan
description: [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution
arm group label: [14C]-lasmiditan
other name: LY573144
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lasmiditan
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 