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A Phase 2, Double-Blind, Repeat-Dose, Placebo-Controlled Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CRD-4730 in Participants With Catecholaminergic Polymorphic Ventricular Tachycardia
Led by Cardurion Pharmaceuticals, Inc. · Updated on 2026-02-27
12
Participants Needed
9
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating CRD-4730 in adults with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT), a rare heart rhythm condition. This Phase 2, multicenter, double-blind study compares the safety, tolerability, and how the body processes and responds to CRD-4730 versus placebo. The study aims to better understand CRD-4730's effects in participants confirmed to have CPVT through genetic testing and clinical evaluation. Participants will take part in a randomized, three-period crossover trial where each individual receives two different doses of CRD-4730 and one matching placebo dose in varied sequences. The treatments are given as oral tablets over the study periods, with careful monitoring of responses. This design allows comparison of the drug’s impact at different doses and against placebo within the same participants. Throughout the study, participants will undergo exercise stress tests and other clinical assessments to measure heart rhythm changes and drug effects. Researchers will monitor safety, tolerability, and pharmacokinetics from baseline up to Day 101. Participants must maintain stable antiarrhythmic medication doses and adhere to contraceptive guidelines. The study includes detailed follow-ups to evaluate outcomes and ensure participant well-being during and after the trial.
CONDITIONS
Brief Title
A Phase 2 Study of CRD-4730 in CPVT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older and legally an adult
- Confirmed CPVT diagnosis based on genetic screening for a pathogenic RYR2 mutation and consistent clinical phenotype
- Ability to perform an exercise stress test showing frequent premature ventricular contractions (10 or more per minute), ventricular bigeminy, or higher-grade ventricular arrhythmia
- Stable dose of at least one antiarrhythmic medication (excluding amiodarone) for at least 4 weeks prior to screening, unless unable to tolerate antiarrhythmic therapy
- Adherence to all contraceptive requirements
You will not qualify if you...
- Clinically significant structural heart disease, heart failure, or coronary artery disease
- Clinically significant abnormal ECG not explained by CPVT or abnormal intervals such as prolonged QT
- History of myocardial infarction, cerebrovascular accident, or transient ischemic attack within 3 months prior to screening
- Implantable cardioverter-defibrillator implantation or sympathetic nerve denervation within 3 months prior to screening
- Anticipated change in exercise regimen or new exercise program during the study
- History of malignancy within 5 years prior to screening except certain skin carcinomas or cervical carcinoma in situ; prior chest radiation exposure excluded
- Abnormal blood pressure or symptomatic heart rate abnormalities at screening or Day 1
- Hepatic impairment with ALT or AST over 3 times upper limit of normal or total bilirubin over 1.5 times upper limit of normal unless due to Gilbert syndrome
- Acute or chronic hepatitis B, hepatitis C, or HIV infection
- Pregnancy, breastfeeding, or plans to become pregnant during the study or within 3 months after last study drug dose
- Use of additional antiarrhythmic drugs outside stable regimen within 5 half-lives prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 101 days
Participants receive oral CRD-4730 or placebo tablets in a randomized crossover design to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics.
Multiple visits during the treatment periods as per study schedule
Trial Site Locations
Total: 9 locations
1
Cardurion Investigative Site
San Francisco, California, United States, 94143
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2
Cardurion Investigative Site
Morrisville, North Carolina, United States, 27560
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3
Cardurion Investigative Site
Houston, Texas, United States, 77030
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4
Cardurion Investigative Site
Madison, Wisconsin, United States, 53792
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5
Cardurion Investigative Site
Vancouver, British Columbia, Canada, V6Z 1Y6
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6
Cardurion Investigative Site
Saint-Herblain, France, 44800
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7
Cardurion Investigative Site
Pavia, Pavia, Italy, 27100
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8
Cardurion Investigative Site
Amsterdam, North Holland, Netherlands, 1105 AZ
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9
Cardurion Investigative Site
Esplugues de Llobregat, Barcelona, Spain, 08950
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Research Team
J
Jason Homsy, MD, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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