TERMINATED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2A, Investigator & Subject Blinded, Sponsor Unblinded, Placebo-Controlled, Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of CRD-4730 in Participants With Catecholaminergic Polymorphic Ventricular Tachycardia

Quick Facts

Study Start:2023-11-07
Study Completion:2025-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06005428

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Males or Females ≥18 years of age, at screening.
  2. 2. Confirmed CPVT diagnosis, based on genetic screening for a known RyR2 mutation and a clinical phenotype consistent with CPVT at screening.
  3. 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. 4. Stable doses of any anti-arrhythmic medication, except amiodarone, for 4 weeks prior to screening.
  5. 5. Adhere to all contraceptive criteria.
  1. 1. Clinically significant structural heart disease, diagnosis of heart failure, or clinically significant coronary artery disease.
  2. 2. History of a myocardial infarction, cerebrovascular accident, or transient ischemic attack within 3 months of screening.
  3. 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. 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. 5. Use of amiodarone with 3 months prior to screening. NOTE: other protocol defined Inclusion/ Exclusion criteria may apply.

Contacts and Locations

Principal Investigator

Jason Homsy, M.D., Ph.D.
STUDY_DIRECTOR
Executive Medical Director

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Cleveland Clinic Children's Hospital
Cleveland, Ohio, 44195
United States
Baylor College of Medicine
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Cardurion Pharmaceuticals, Inc.

  • Jason Homsy, M.D., Ph.D., STUDY_DIRECTOR, Executive Medical Director

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-07
Study Completion Date2025-05-31

Study Record Updates

Study Start Date2023-11-07
Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

  • CaMKII
  • Catecholaminergic polymorphic VT
  • Ventricular Tachycardia
  • CRD-4730

Additional Relevant MeSH Terms

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