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

Heart Diseases | Ventricular Tachycardia | Heart Defects, Congenital | CPVT1

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.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    18 and up

Participation Criteria

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 a clinical phenotype consistent with CPVT at screening.
3. The participant can perform an EST during which frequent premature ventricular contraction (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 prior to screening.
5. Adhere to all contraceptive criteria.

Exclusion Criteria:

1. Clinically significant structural heart disease, diagnosis of heart failure, or clinically significant coronary artery disease.
2. History of a myocardial infarction, cerebrovascular accident, or transient ischemic attack within 3 months of screening.
3. History of malignancy within the past 5 years at screening (except successfully treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ).
4. Female participant that is pregnant or lactating/ breastfeeding, or has plans to do so 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 defined Inclusion/ Exclusion criteria may apply.

Study Location

University of British Columbia (UBC) Hospital
University of British Columbia (UBC) Hospital
Vancouver, British Columbia
Canada

Contact Study Team

Backup Contact

Andrew Krahn, MD

Primary Contact

Andrew Krahn, MD

[email protected]
(604) 875-5069
Stollery Children's Hospital University of Alberta
Stollery Children's Hospital University of Alberta
Edmonton, Alberta
Canada

Contact Study Team

Primary Contact

Bobby Guobadia

[email protected]
(780) 248-5607
Backup Contact

Joseph Atallah, MD

British Columbia Children's Hospital
British Columbia Children's Hospital
Vancouver, British Columbia
Canada

Contact Study Team

Primary Contact

Sonia Franciosi

[email protected]
(604) 875-2295
Backup Contact

Shubhayan Sanatani, MD

University of Western Ontario
University of Western Ontario
London, Ontario
Canada

Contact Study Team

Backup Contact

Habib Khan, MD

Primary Contact

Michelle Shillington

[email protected]
(519) 685-8500
Study Sponsored By
Cardurion Pharmaceuticals, Inc.
Participants Required
More Information
Study ID: NCT06005428