<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/NCT03819270</url>
  </required_header>
  <id_info>
    <org_study_id>17219</org_study_id>
    <secondary_id>I9X-MC-MTAA</secondary_id>
    <nct_id>NCT03819270</nct_id>
  </id_info>
  <brief_title>A Safety Study of LY3372689 Given By Mouth to Healthy Participants</brief_title>
  <official_title>Single-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3372689</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being conducted to determine the safety profile of the study drug after it is&#xD;
      given by mouth to healthy participants. Blood tests will be performed to check how much&#xD;
      LY3372689 gets into the bloodstream and how long the body takes to get rid of it. Each&#xD;
      enrolled participant will receive up to 3 doses of LY3372689 or placebo. The study will last&#xD;
      about 12 weeks, including screening.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2019</start_date>
  <completion_date type="Actual">June 24, 2019</completion_date>
  <primary_completion_date type="Actual">June 23, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with One or More Serious Adverse Event(s) (SAEs) Observed by the Investigator During Study Drug Administration</measure>
    <time_frame>Baseline through final follow-up at approximately Week 12</time_frame>
    <description>A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Maximum Concentration (Cmax) of LY3372689</measure>
    <time_frame>Baseline through to final follow-up at approximately Week 12</time_frame>
    <description>Pharmacokinetics: Cmax of LY3372689</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Time to Maximum Blood Concentration (Tmax) of LY3372689</measure>
    <time_frame>Baseline through final follow-up at approximately Week 12</time_frame>
    <description>Pharmacokinetics: Tmax of LY3372689</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3372689</measure>
    <time_frame>Baseline through final follow-up at approximately Week 12</time_frame>
    <description>Pharmacokinetics: AUC of LY3372689</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>LY3372689</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Escalating doses of LY3372689 administered orally in healthy participants in two of three study periods</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo administered orally in healthy participants in one of three study periods</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3372689</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>LY3372689</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overtly healthy male or a female who cannot get pregnant&#xD;
&#xD;
          -  Have a body mass index (BMI) of at least 18.5 kilogram per square meter (kg/m²),&#xD;
             inclusive, at screening&#xD;
&#xD;
          -  Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood&#xD;
             and urine laboratory test results that are acceptable for the study&#xD;
&#xD;
          -  Have veins suitable for ease of blood sampling&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are currently participating in or completed a clinical trial within the last 30 days&#xD;
             or any other type of medical research judged to be incompatible with this study&#xD;
&#xD;
          -  Have previously participated or withdrawn from this study&#xD;
&#xD;
          -  Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop&#xD;
             smoking for study procedure&#xD;
&#xD;
          -  Have or used to have health problems or laboratory test results or ECG readings that,&#xD;
             in the opinion of the doctor, could make it unsafe to participate, or could interfere&#xD;
             with understanding the results of the study&#xD;
&#xD;
          -  Have long exposure to sunlight routinely or use tanning beds regularly&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75247</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 1, 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>July 2, 2019</last_update_submitted>
  <last_update_submitted_qc>July 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03819270
org study id: 17219
secondary id: I9X-MC-MTAA
nct id: NCT03819270
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study is being conducted to determine the safety profile of the study drug after it is
      given by mouth to healthy participants. Blood tests will be performed to check how much
      LY3372689 gets into the bloodstream and how long the body takes to get rid of it. Each
      enrolled participant will receive up to 3 doses of LY3372689 or placebo. The study will last
      about 12 weeks, including screening.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Observed by the Investigator During Study Drug Administration
time frame: Baseline through final follow-up at approximately Week 12
description: A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY3372689
time frame: Baseline through to final follow-up at approximately Week 12
description: Pharmacokinetics: Cmax of LY3372689
measure: Pharmacokinetics: Time to Maximum Blood Concentration (Tmax) of LY3372689
time frame: Baseline through final follow-up at approximately Week 12
description: Pharmacokinetics: Tmax of LY3372689
measure: Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3372689
time frame: Baseline through final follow-up at approximately Week 12
description: Pharmacokinetics: AUC of LY3372689
arm group label: LY3372689
arm group type: Experimental
description: Escalating doses of LY3372689 administered orally in healthy participants in two of three study periods
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching placebo administered orally in healthy participants in one of three study periods
intervention type: Drug
intervention name: LY3372689
description: Administered orally
arm group label: LY3372689
intervention type: Drug
intervention name: Placebo
description: Administered orally
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No