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/NCT06005428</url>
    </required_header>
    <id_info>
      <org_study_id>CRD-4730-201</org_study_id>
      <nct_id>NCT06005428</nct_id>
    </id_info>
    <brief_title>Effectiveness of CRD-4730 in Participants With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)</brief_title>
    <acronym>CPVT</acronym>
    <official_title>A Phase 2A, Investigator &amp; Subject Blinded, Sponsor Unblinded, Placebo-Controlled, Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of CRD-4730 in Participants With Catecholaminergic Polymorphic Ventricular Tachycardia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cardurion Pharmaceuticals, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cardurion Pharmaceuticals, Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a Phase 2, multicenter, double-blind, sponsor unblinded, placebo-controlled,&#xD;
        single-dose clinical study of CRD-4730 to evaluate the safety, tolerability, pharmacokinetics&#xD;
        (PK), and pharmacodynamics (PD) of CRD-4730 when administered as single oral doses to&#xD;
        participants with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). The study&#xD;
        will have 2 cohorts in which participants with CPVT will participate in a 3-period,&#xD;
        randomized 2-sequence study. Each participant will receive 2 different doses of CRD-4730 and&#xD;
        1 dose of matching placebo, with each study drug administered as a single dose.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 29, 2024</primary_completion_date>
    <phase>Phase 2</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>
      <intervention_model_description>3-period randomized 2-sequence study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Investigator and Subject Blinded, Sponsor Unblinded; Placebo-controlled</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Treatment Emergent Adverse Events (TEAEs)</measure>
      <time_frame>Baseline to Day 22</time_frame>
      <description>The number of participants with TEAEs including drug-related AEs, serious AEs (SAEs), and AEs leading to study drug discontinuation will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in Laboratory Assessments</measure>
      <time_frame>Baseline to Day 15</time_frame>
      <description>The number of participants who have normal/ abnormal values at Baseline compared to normal/ abnormal values post-Baseline will be assessed for hematology, serum chemistry and urinalysis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in Vital Signs Measurement: Systolic and Diastolic blood pressure</measure>
      <time_frame>Baseline to Day 15</time_frame>
      <description>Percent change from Baseline to post Baseline will be assessed for systolic and diastolic blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in Vital Signs Measurement: Pulse Rate</measure>
      <time_frame>Baseline to Day 15</time_frame>
      <description>Percent change from Baseline to post Baseline will be assessed for pulse rate</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in Vital Signs Measurement: Respiratory Rate</measure>
      <time_frame>Baseline to Day 15</time_frame>
      <description>Percent change from Baseline to post Baseline will be assessed for respiratory rate</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in Vital Signs Measurement: Body Temperature</measure>
      <time_frame>Baseline to Day 15</time_frame>
      <description>Percent change from Baseline to post Baseline will be assessed for body temperature</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in Physical Exam</measure>
      <time_frame>Baseline to Day 22</time_frame>
      <description>General physical exams will be carried out to detect any abnormalities in the cardiovascular, respiratory and other body systems</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in Electrocardiogram (ECG) Measurements</measure>
      <time_frame>Baseline to Day 22</time_frame>
      <description>Number of participants who have normal/abnormal ECG measurements at Baseline will be compared to normal/abnormal ECG measurement post Baseline</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Ventricular Arrhythmia (VA) score during Exercise Stress Test (EST)</measure>
      <time_frame>Baseline to Day 1</time_frame>
      <description>The VA score is a physician administered score on a scale of 0-5 with higher numbers being worse.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Ventricular Arrhythmia (VA) score during Exercise Stress Test (EST)</measure>
      <time_frame>Baseline to Day 8</time_frame>
      <description>The VA score is a physician administered score on a scale of 0-5 with higher numbers being worse.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Ventricular Arrhythmia (VA) score during Exercise Stress Test (EST)</measure>
      <time_frame>Baseline to Day 15</time_frame>
      <description>The VA score is a physician administered score on a scale of 0-5 with higher numbers being worse.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment of PK effect</measure>
      <time_frame>Baseline through Day 15</time_frame>
      <description>Plasma concentrations of CRD-4730 over time for each treatment period</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>CPVT1</condition>
    <condition>Heart Defects, Congenital</condition>
    <condition>Heart Diseases</condition>
    <condition>Ventricular Tachycardia</condition>
    <arm_group>
      <arm_group_label>Dose 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>CRD-4730 Dose 1 capsule</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dose 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>CRD-4730 Dose 2 capsule</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dose 3</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo capsule to match CRD-4730</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CRD-4730</intervention_name>
      <description>Oral CRD-4730 in capsule form</description>
      <arm_group_label>Dose 1</arm_group_label>
      <arm_group_label>Dose 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo to match CRD-4730 in capsule form</description>
      <arm_group_label>Dose 3</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Males or Females ≥18 years of age, at screening.&#xD;
  &#xD;
            2. Confirmed CPVT diagnosis, based on genetic screening for a known RyR2 mutation and a&#xD;
               clinical phenotype consistent with CPVT at screening.&#xD;
  &#xD;
            3. Ability to perform an Exercise Stress Test (EST) during which exercise-induced&#xD;
               ventricular couplets or higher-grade VA (equivalent to a VA score ≥3) are identified&#xD;
               by the investigator.&#xD;
  &#xD;
            4. Stable doses of any anti-arrhythmic medication, except amiodarone, for 4 weeks prior&#xD;
               to screening.&#xD;
  &#xD;
            5. Adhere to all contraceptive criteria.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Clinically significant structural heart disease, diagnosis of heart failure, or&#xD;
               clinically significant coronary artery disease.&#xD;
  &#xD;
            2. History of a myocardial infarction, cerebrovascular accident, or transient ischemic&#xD;
               attack within 3 months of screening.&#xD;
  &#xD;
            3. History of malignancy within the past 5 years at screening (except successfully&#xD;
               treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or&#xD;
               cervical carcinoma in situ).&#xD;
  &#xD;
            4. Female participant that is pregnant or lactating/ breastfeeding, or has plans to do so&#xD;
               during the study or within 3 months following last dose of study drug.&#xD;
  &#xD;
            5. Use of amiodarone with 3 months prior to screening. NOTE: other protocol defined&#xD;
               Inclusion/ Exclusion criteria may apply.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jason Homsy, M.D., Ph.D.</last_name>
      <role>Study Director</role>
      <affiliation>Executive Medical Director</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jason Homsy, M.D., Ph.D.</last_name>
      <phone>(617) 863-8088</phone>
      <email>jason.homsy@cardurion.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>CaMKII</keyword>
    <keyword>Catecholaminergic polymorphic VT</keyword>
    <keyword>Ventricular Tachycardia</keyword>
    <keyword>CRD-4730</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Diseases</mesh_term>
      <mesh_term>Tachycardia</mesh_term>
      <mesh_term>Tachycardia, Ventricular</mesh_term>
      <mesh_term>Heart Defects, Congenital</mesh_term>
      <mesh_term>Congenital Abnormalities</mesh_term>
    </condition_browse>
    <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/NCT06005428
  org study id: CRD-4730-201
  nct id: NCT06005428
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a Phase 2, multicenter, double-blind, sponsor unblinded, placebo-controlled,
        single-dose clinical study of CRD-4730 to evaluate the safety, tolerability, pharmacokinetics
        (PK), and pharmacodynamics (PD) of CRD-4730 when administered as single oral doses to
        participants with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). The study
        will have 2 cohorts in which participants with CPVT will participate in a 3-period,
        randomized 2-sequence study. Each participant will receive 2 different doses of CRD-4730 and
        1 dose of matching placebo, with each study drug administered as a single dose.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: 3-period randomized 2-sequence study
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Investigator and Subject Blinded, Sponsor Unblinded; Placebo-controlled
  measure: Treatment Emergent Adverse Events (TEAEs)
  time frame: Baseline to Day 22
  description: The number of participants with TEAEs including drug-related AEs, serious AEs (SAEs), and AEs leading to study drug discontinuation will be assessed.
  measure: Changes in Laboratory Assessments
  time frame: Baseline to Day 15
  description: The number of participants who have normal/ abnormal values at Baseline compared to normal/ abnormal values post-Baseline will be assessed for hematology, serum chemistry and urinalysis.
  measure: Changes in Vital Signs Measurement: Systolic and Diastolic blood pressure
  time frame: Baseline to Day 15
  description: Percent change from Baseline to post Baseline will be assessed for systolic and diastolic blood pressure
  measure: Changes in Vital Signs Measurement: Pulse Rate
  time frame: Baseline to Day 15
  description: Percent change from Baseline to post Baseline will be assessed for pulse rate
  measure: Changes in Vital Signs Measurement: Respiratory Rate
  time frame: Baseline to Day 15
  description: Percent change from Baseline to post Baseline will be assessed for respiratory rate
  measure: Changes in Vital Signs Measurement: Body Temperature
  time frame: Baseline to Day 15
  description: Percent change from Baseline to post Baseline will be assessed for body temperature
  measure: Changes in Physical Exam
  time frame: Baseline to Day 22
  description: General physical exams will be carried out to detect any abnormalities in the cardiovascular, respiratory and other body systems
  measure: Changes in Electrocardiogram (ECG) Measurements
  time frame: Baseline to Day 22
  description: Number of participants who have normal/abnormal ECG measurements at Baseline will be compared to normal/abnormal ECG measurement post Baseline
  measure: Change in Ventricular Arrhythmia (VA) score during Exercise Stress Test (EST)
  time frame: Baseline to Day 1
  description: The VA score is a physician administered score on a scale of 0-5 with higher numbers being worse.
  measure: Change in Ventricular Arrhythmia (VA) score during Exercise Stress Test (EST)
  time frame: Baseline to Day 8
  description: The VA score is a physician administered score on a scale of 0-5 with higher numbers being worse.
  measure: Change in Ventricular Arrhythmia (VA) score during Exercise Stress Test (EST)
  time frame: Baseline to Day 15
  description: The VA score is a physician administered score on a scale of 0-5 with higher numbers being worse.
  measure: Assessment of PK effect
  time frame: Baseline through Day 15
  description: Plasma concentrations of CRD-4730 over time for each treatment period
  arm group label: Dose 1
  arm group type: Experimental
  description: CRD-4730 Dose 1 capsule
  arm group label: Dose 2
  arm group type: Experimental
  description: CRD-4730 Dose 2 capsule
  arm group label: Dose 3
  arm group type: Placebo Comparator
  description: Placebo capsule to match CRD-4730
  intervention type: Drug
  intervention name: CRD-4730
  description: Oral CRD-4730 in capsule form
  arm group label: Dose 1
  arm group label: Dose 2
  intervention type: Drug
  intervention name: Placebo
  description: Placebo to match CRD-4730 in capsule form
  arm group label: Dose 3
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Jason Homsy, M.D., Ph.D.
  role: Study Director
  affiliation: Executive Medical Director
  last name: Jason Homsy, M.D., Ph.D.
  phone: (617) 863-8088
  email: jason.homsy@cardurion.com
  responsible party type: Sponsor
  mesh term: Heart Diseases
  mesh term: Tachycardia
  mesh term: Tachycardia, Ventricular
  mesh term: Heart Defects, Congenital
  mesh term: Congenital Abnormalities
  sharing ipd: No