Effectiveness of CRD-4730 in Participants with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

Last updated: January 17, 2025
Sponsor: Cardurion Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Holoprosencephaly

Heart Defect

Arrhythmia

Treatment

Placebo

CRD-4730

Clinical Study ID

NCT06005428
CRD-4730-201
  • Ages 18-99
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Males or Females ≥18 years of age, at screening.

  2. Confirmed CPVT diagnosis, based on genetic screening for a known RyR2 mutation and aclinical phenotype consistent with CPVT at screening.

  3. The participant can perform an EST during which frequent premature ventricularcontraction (PVCs) (≥10 per minute), ventricular bigeminy, or higher-grade VA (equivalent to a VA score ≥2) are identified by the investigator.

  4. Stable doses of any anti-arrhythmic medication, except amiodarone, for 4 weeks priorto screening.

  5. Adhere to all contraceptive criteria.

Exclusion

Exclusion Criteria:

  1. Clinically significant structural heart disease, diagnosis of heart failure, orclinically significant coronary artery disease.

  2. History of a myocardial infarction, cerebrovascular accident, or transient ischemicattack within 3 months of screening.

  3. History of malignancy within the past 5 years at screening (except successfullytreated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skinor cervical carcinoma in situ).

  4. Female participant that is pregnant or lactating/ breastfeeding, or has plans to doso during the study or within 3 months following last dose of study drug.

  5. Use of amiodarone with 3 months prior to screening. NOTE: other protocol definedInclusion/ Exclusion criteria may apply.

Study Design

Total Participants: 12
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
November 07, 2023
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Cardurion Investigative Site

    Edmonton, Alberta T6G 2R7
    Canada

    Site Not Available

  • Stollery Children's Hospital University of Alberta

    Edmonton, Alberta T6G 2R7
    Canada

    Active - Recruiting

  • British Columbia Children's Hospital

    Vancouver, British Columbia V6H 3N1
    Canada

    Active - Recruiting

  • Cardurion Investigative Site

    Vancouver, British Columbia V6Z1Y6
    Canada

    Site Not Available

  • University of British Columbia (UBC) Hospital

    Vancouver, British Columbia V5Z 1M9
    Canada

    Active - Recruiting

  • Cardurion Investigative Site

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • University of Western Ontario

    London, Ontario N6A 5A5
    Canada

    Active - Recruiting

  • Cardurion Investigative Site

    Nantes, Loire-Atlantique 44805
    France

    Site Not Available

  • Hôptal Nord Laennec

    Nantes, Loire-Atlantique 44805
    France

    Active - Recruiting

  • Cardurion Investigative Site

    Bron, 69677
    France

    Site Not Available

  • Hôpital Louis Pradel

    Bron, 69677
    France

    Active - Recruiting

  • Cardurion Investigative Site

    Paris, 75018
    France

    Site Not Available

  • Groupe Hospitalier Bichat Claude Bernard

    Paris, 75018
    France

    Active - Recruiting

  • Cardurion Investigative Site

    Saint-Herblain, 44800
    France

    Site Not Available

  • Cardurion Investigative Site

    Pavia, Lombardia 27100
    Italy

    Site Not Available

  • IRCCS Pavia Istituti Clinici Scientifici Maugeri Spa Società Benefit

    Pavia, Lombardia 27100
    Italy

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Cardurion Investigative Site

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic Children's Hospital

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Cardurion Investigative Site

    Houston, Texas 77030
    United States

    Site Not Available

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