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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: CPVT1, Heart Defects, Congenital, Heart Diseases, Ventricular Tachycardia

In brief

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.

Key facts

Study ID: NCT06005428
Run by: Cardurion Pharmaceuticals, Inc.
People needed: 7
Starts: 2023-11-07
Expected to finish: 2025-05-31
Last updated by the study team: 2026-05-27

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Males or Females ≥18 years of age, at screening.
Confirmed CPVT diagnosis, based on genetic screening for a known RyR2 mutation and a clinical phenotype consistent with CPVT at screening.
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.
Stable doses of any anti-arrhythmic medication, except amiodarone, for 4 weeks prior to screening.
Adhere to all contraceptive criteria.

You may not qualify if…

Clinically significant structural heart disease, diagnosis of heart failure, or clinically significant coronary artery disease.
History of a myocardial infarction, cerebrovascular accident, or transient ischemic attack within 3 months of screening.
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).
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.
Use of amiodarone with 3 months prior to screening. NOTE: other protocol defined Inclusion/ Exclusion criteria may apply.

Where it is running

Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Cleveland Clinic Children&#39;s Hospital — Cleveland, Ohio, United States
Baylor College of Medicine — Houston, Texas, United States
Stollery Children&#39;s Hospital University of Alberta — Edmonton, Alberta, Canada
University of British Columbia (UBC) Hospital — Vancouver, British Columbia, Canada
British Columbia Children&#39;s Hospital — Vancouver, British Columbia, Canada
University of Western Ontario — London, Ontario, Canada
Hôptal Nord Laennec — Nantes, Loire-Atlantique, France
Hôpital Louis Pradel — Bron, France
Groupe Hospitalier Bichat Claude Bernard — Paris, France
IRCCS Pavia Istituti Clinici Scientifici Maugeri Spa Società Benefit — Pavia, Lombardy, Italy

Full record on ClinicalTrials.gov

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