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/NCT06011317</url>
    </required_header>
    <id_info>
      <org_study_id>EDG-7500-101</org_study_id>
      <nct_id>NCT06011317</nct_id>
    </id_info>
    <brief_title>A Study of EDG-7500 in Healthy Adults</brief_title>
    <official_title>A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-7500 in Healthy Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Edgewise Therapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Edgewise Therapeutics, Inc.</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purposes of this Phase 1 study of EDG-7500 are to:&#xD;
  &#xD;
          1. Learn about the safety of EDG-7500 after a single and multiple doses in healthy adults&#xD;
  &#xD;
          2. Learn about how EDG-7500 is tolerated after a single and multiples doses in healthy&#xD;
             adults&#xD;
  &#xD;
          3. Evaluate the amount of EDG-7500 is in the blood and urine after single and multiple&#xD;
             doses in healthy adults&#xD;
  &#xD;
          4. Evaluate the effect of a meal on the amount of EDG-7500 that is in the blood in healthy&#xD;
             adults&#xD;
  &#xD;
          5. Evaluate whether the amount of EDG-7500 in the blood is similar for the suspension and&#xD;
             tablet forms of EDG-7500 in healthy adults&#xD;
  &#xD;
        Participants will receive a single or multiple doses of EDG-7500 or a placebo by mouth.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 14, 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Safety: incidence of treatment-emergent adverse events</measure>
      <time_frame>Up to 25 days of monitoring</time_frame>
      <description>To assess the safety and tolerability of EDG-7500 when administered as single and multiple doses</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Determination of pharmacokinetics parameters as measured by Tmax</measure>
      <time_frame>Up to 25 days of monitoring</time_frame>
      <description>Time to maximum concentration (Tmax)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determination of pharmacokinetic parameters as measured by Cmax</measure>
      <time_frame>Up to 25 days of monitoring</time_frame>
      <description>Maximum observed concentration (Cmax)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determination of pharmacokinetic parameters as measured by AUC</measure>
      <time_frame>Up to 25 days of monitoring</time_frame>
      <description>Area under the concentration-time curve (AUC)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determination of pharmacokinetic parameters as measured by t1/2</measure>
      <time_frame>Up to 25 days of monitoring</time_frame>
      <description>Terminal half-life (t1/2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determination of renal clearance as measured by CLr</measure>
      <time_frame>Up to 25 days of monitoring</time_frame>
      <description>Renal clearance (CLr)</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">126</enrollment>
    <condition>Healthy Subjects</condition>
    <arm_group>
      <arm_group_label>Part A: Healthy Volunteer (Ages ≥ 18 to &lt; 60 years) Single Ascending Dose</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single oral ascending dose in healthy volunteers ages ≥ 18 to &lt; 60 years</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part B: Healthy Volunteer (Ages ≥ 18 to &lt; 60 years) Multiple Ascending Doses</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Multiple oral ascending doses in healthy volunteers ages ≥ 18 to &lt; 60 years</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part C: Healthy Volunteers (Ages ≥ 60 to ≤ 72 years) Multiple Ascending Doses</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Multiple oral ascending doses in healthy volunteers ages ≥ 60 to ≤ 72 years</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part D: Healthy Volunteer Food Effect and Relative Bioavailability</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Crossover food effect (fed versus fasted) single oral dose in healthy volunteers and relative bioavailability of liquid versus solid formulation</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>EDG-7500</intervention_name>
      <description>EDG-7500 is administered orally once daily</description>
      <arm_group_label>Part A: Healthy Volunteer (Ages ≥ 18 to &lt; 60 years) Single Ascending Dose</arm_group_label>
      <arm_group_label>Part B: Healthy Volunteer (Ages ≥ 18 to &lt; 60 years) Multiple Ascending Doses</arm_group_label>
      <arm_group_label>Part C: Healthy Volunteers (Ages ≥ 60 to ≤ 72 years) Multiple Ascending Doses</arm_group_label>
      <arm_group_label>Part D: Healthy Volunteer Food Effect and Relative Bioavailability</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo is administered orally once daily</description>
      <arm_group_label>Part A: Healthy Volunteer (Ages ≥ 18 to &lt; 60 years) Single Ascending Dose</arm_group_label>
      <arm_group_label>Part B: Healthy Volunteer (Ages ≥ 18 to &lt; 60 years) Multiple Ascending Doses</arm_group_label>
      <arm_group_label>Part C: Healthy Volunteers (Ages ≥ 60 to ≤ 72 years) Multiple Ascending Doses</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Willing and able to give informed consent and follow all study procedures and&#xD;
               requirements.&#xD;
  &#xD;
            2. Healthy male or nonpregnant female, ages ≥ 18 to ≤ 72 years.&#xD;
  &#xD;
            3. Body mass index (BMI) ≥ 18 to &lt; 35 kg/m2; weight ≥ 55 kg at Screening.&#xD;
  &#xD;
            4. Absence of important health problems and essentially normal physical examination,&#xD;
               normal laboratory screening tests, and normal electrocardiogram (ECG) with QTcF ≤ 450&#xD;
               ms.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Evidence of clinically significant abnormalities or disease.&#xD;
  &#xD;
            2. Unless permitted by protocol, use of any prescription medication ≤ 4 weeks or&#xD;
               investigational medication ≤ 12 weeks or ≤ 5 half-lives (whichever is longer) of&#xD;
               dosing. Use of any non-prescription medication or herbal/nutritional supplement ≤ 5&#xD;
               days prior to dosing.&#xD;
  &#xD;
            3. Donation or loss of &gt; 1 unit (450 mL) of blood ≤ 1 month prior to dosing.&#xD;
  &#xD;
            4. Females: nursing, lactating, or pregnant.&#xD;
  &#xD;
            5. Females: breast implants.&#xD;
  &#xD;
            6. Use of nicotine-containing products in the last 6 months prior to dosing.&#xD;
  &#xD;
            7. History of substance abuse or dependency or history of recreational drug use. Alcohol&#xD;
               consumption &gt; 14 drinks per week for males (7 for females). Positive screen for drugs&#xD;
               of abuse or alcohol or cotinine test at Screening or Admission.&#xD;
  &#xD;
          Additional protocol defined inclusion/exclusion criteria may apply.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>72 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Medical Director</last_name>
      <role>Study Director</role>
      <affiliation>Edgewise Therapeutics, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Edgewise Therapeutics</last_name>
      <phone>720-262-7002</phone>
      <email>cardiacstudies@edgewisetx.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Celerion</name>
        <address>
          <city>Lincoln</city>
          <state>Nebraska</state>
          <zip>68502</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 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/NCT06011317
  org study id: EDG-7500-101
  nct id: NCT06011317
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  The purposes of this Phase 1 study of EDG-7500 are to:
  
          1. Learn about the safety of EDG-7500 after a single and multiple doses in healthy adults
  
          2. Learn about how EDG-7500 is tolerated after a single and multiples doses in healthy
             adults
  
          3. Evaluate the amount of EDG-7500 is in the blood and urine after single and multiple
             doses in healthy adults
  
          4. Evaluate the effect of a meal on the amount of EDG-7500 that is in the blood in healthy
             adults
  
          5. Evaluate whether the amount of EDG-7500 in the blood is similar for the suspension and
             tablet forms of EDG-7500 in healthy adults
  
        Participants will receive a single or multiple doses of EDG-7500 or a placebo by mouth.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Safety: incidence of treatment-emergent adverse events
  time frame: Up to 25 days of monitoring
  description: To assess the safety and tolerability of EDG-7500 when administered as single and multiple doses
  measure: Determination of pharmacokinetics parameters as measured by Tmax
  time frame: Up to 25 days of monitoring
  description: Time to maximum concentration (Tmax)
  measure: Determination of pharmacokinetic parameters as measured by Cmax
  time frame: Up to 25 days of monitoring
  description: Maximum observed concentration (Cmax)
  measure: Determination of pharmacokinetic parameters as measured by AUC
  time frame: Up to 25 days of monitoring
  description: Area under the concentration-time curve (AUC)
  measure: Determination of pharmacokinetic parameters as measured by t1/2
  time frame: Up to 25 days of monitoring
  description: Terminal half-life (t1/2)
  measure: Determination of renal clearance as measured by CLr
  time frame: Up to 25 days of monitoring
  description: Renal clearance (CLr)
  arm group label: Part A: Healthy Volunteer (Ages ≥ 18 to < 60 years) Single Ascending Dose
  arm group type: Experimental
  description: Single oral ascending dose in healthy volunteers ages ≥ 18 to < 60 years
  arm group label: Part B: Healthy Volunteer (Ages ≥ 18 to < 60 years) Multiple Ascending Doses
  arm group type: Experimental
  description: Multiple oral ascending doses in healthy volunteers ages ≥ 18 to < 60 years
  arm group label: Part C: Healthy Volunteers (Ages ≥ 60 to ≤ 72 years) Multiple Ascending Doses
  arm group type: Experimental
  description: Multiple oral ascending doses in healthy volunteers ages ≥ 60 to ≤ 72 years
  arm group label: Part D: Healthy Volunteer Food Effect and Relative Bioavailability
  arm group type: Experimental
  description: Crossover food effect (fed versus fasted) single oral dose in healthy volunteers and relative bioavailability of liquid versus solid formulation
  intervention type: Drug
  intervention name: EDG-7500
  description: EDG-7500 is administered orally once daily
  arm group label: Part A: Healthy Volunteer (Ages ≥ 18 to < 60 years) Single Ascending Dose
  arm group label: Part B: Healthy Volunteer (Ages ≥ 18 to < 60 years) Multiple Ascending Doses
  arm group label: Part C: Healthy Volunteers (Ages ≥ 60 to ≤ 72 years) Multiple Ascending Doses
  arm group label: Part D: Healthy Volunteer Food Effect and Relative Bioavailability
  intervention type: Drug
  intervention name: Placebo
  description: Placebo is administered orally once daily
  arm group label: Part A: Healthy Volunteer (Ages ≥ 18 to < 60 years) Single Ascending Dose
  arm group label: Part B: Healthy Volunteer (Ages ≥ 18 to < 60 years) Multiple Ascending Doses
  arm group label: Part C: Healthy Volunteers (Ages ≥ 60 to ≤ 72 years) Multiple Ascending Doses
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 72 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Medical Director
  role: Study Director
  affiliation: Edgewise Therapeutics, Inc.
  last name: Edgewise Therapeutics
  phone: 720-262-7002
  email: cardiacstudies@edgewisetx.com
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  sharing ipd: No