xml: <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/NCT06028425</url>
    </required_header>
    <id_info>
      <org_study_id>LOXO-PIK-22004</org_study_id>
      <secondary_id>J4C-OX-JZUC</secondary_id>
      <nct_id>NCT06028425</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Effect of Food on LOXO-783 in Healthy Participants</brief_title>
    <official_title>A Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of LOXO-783 in Healthy Adult Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eli Lilly and Company</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Loxo Oncology, Inc.</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>
        The main purpose of this study is to measure how much of LOXO-783 is in the bloodstream and&#xD;
        how the body handles and eliminates LOXO-783 when administered in fasting and fed states in&#xD;
        healthy participants. The study will also evaluate the safety and tolerability of LOXO-783.&#xD;
        Participation could last up to 63 days including screening period.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 2, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783</measure>
      <time_frame>Predose on Day 1 up to 96 hours postdose</time_frame>
      <description>PK: Cmax of LOXO-783</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC [0-∞]) of LOXO-783</measure>
      <time_frame>Predose on Day 1 up to 96 hours postdose</time_frame>
      <description>PK: AUC [0-∞] of LOXO-783</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">42</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>LOXO-783 (Fasted State)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>LOXO-783 administered orally to participants who are in fasted state</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LOXO-783 (Fed State - Low Fat Meal)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>LOXO-783 administered orally to participants who are on low fat meal</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LOXO-783 (Fed State - High Fat Meal)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>LOXO-783 administered orally to participants who are on high fat meal</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LOXO-783</intervention_name>
      <description>Administered orally.</description>
      <arm_group_label>LOXO-783 (Fasted State)</arm_group_label>
      <arm_group_label>LOXO-783 (Fed State - High Fat Meal)</arm_group_label>
      <arm_group_label>LOXO-783 (Fed State - Low Fat Meal)</arm_group_label>
      <other_name>LY3849524</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy status as defined by the absence of evidence of any clinically significant&#xD;
               active or chronic disease&#xD;
  &#xD;
            -  Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Females who are lactating or of childbearing potential&#xD;
  &#xD;
            -  Clinically significant history of any drug sensitivity, drug allergy, or food allergy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yingying Guo-Avrutin, MD, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Loxo Oncology, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Patient Advocacy</last_name>
      <phone>08555696305</phone>
      <email>clinicaltrials@loxooncology.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fortrea Clinical Research Unit</name>
        <address>
          <city>Daytona Beach</city>
          <state>Florida</state>
          <zip>32117</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <phone>386-366-6400</phone>
      </contact>
      <investigator>
        <last_name>Kathleen Doisy</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</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>
  
  
text: 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/NCT06028425
  org study id: LOXO-PIK-22004
  secondary id: J4C-OX-JZUC
  nct id: NCT06028425
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The main purpose of this study is to measure how much of LOXO-783 is in the bloodstream and
        how the body handles and eliminates LOXO-783 when administered in fasting and fed states in
        healthy participants. The study will also evaluate the safety and tolerability of LOXO-783.
        Participation could last up to 63 days including screening period.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783
  time frame: Predose on Day 1 up to 96 hours postdose
  description: PK: Cmax of LOXO-783
  measure: PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC [0-∞]) of LOXO-783
  time frame: Predose on Day 1 up to 96 hours postdose
  description: PK: AUC [0-∞] of LOXO-783
  arm group label: LOXO-783 (Fasted State)
  arm group type: Experimental
  description: LOXO-783 administered orally to participants who are in fasted state
  arm group label: LOXO-783 (Fed State - Low Fat Meal)
  arm group type: Experimental
  description: LOXO-783 administered orally to participants who are on low fat meal
  arm group label: LOXO-783 (Fed State - High Fat Meal)
  arm group type: Experimental
  description: LOXO-783 administered orally to participants who are on high fat meal
  intervention type: Drug
  intervention name: LOXO-783
  description: Administered orally.
  arm group label: LOXO-783 (Fasted State)
  arm group label: LOXO-783 (Fed State - High Fat Meal)
  arm group label: LOXO-783 (Fed State - Low Fat Meal)
  other name: LY3849524
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yingying Guo-Avrutin, MD, PhD
  role: Study Director
  affiliation: Loxo Oncology, Inc.
  last name: Patient Advocacy
  phone: 08555696305
  email: clinicaltrials@loxooncology.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No