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New treatment option for Catecholaminergic Polymorphic Ventricular Tachycardia
Official title A Phase 2 Study of CRD-4730 in CPVT
ClinicalTrials.gov ID: NCT06658899
What this study is testing
What is CRD-4730?
CRD-4730 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for catecholaminergic polymorphic ventricular tachycardia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 2, multicenter, double-blind, sponsor blinded, placebo-controlled, repeat-dose clinical study of CRD-4730 to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CRD-4730 to participants with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). Participants with CPVT will complete a 3-period, randomized 3-sequence study.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Each participant must meet all the following criteria to be enrolled in this study:
- The participant is male or female, ≥18 years of age and of legal adult age in accordance with local requirements.
- The participant has a confirmed CPVT diagnosis, based on genetic screening for a pathogenic ryanodine receptor (RYR2) mutation and a clinical...
- The participant can perform an EST during which frequent premature ventricular contractions (PVCs; ≥10 per minute), ventricular bigeminy, or...
- The participant has been on a stable dose of at least 1 antiarrhythmic medication (including beta blockers but not amiodarone) for 4 weeks prior to...
You likely can't join if
- Participants meeting any of the following criteria will be excluded from the study:
- The participant has clinically significant structural heart disease, diagnosis of heart failure, or clinically significant coronary artery disease.
- The participant has a clinically significant abnormal ECG not explained by the diagnosis of CPVT at Screening or clinically significant abnormal...
- The participant has a history of a myocardial infarction, cerebrovascular accident, or transient ischemic attack within 3 months of Screening.
- The participant undergoes implantable cardioverter-defibrillator (ICD) implantation or has sympathetic nerve denervation within 3 months of Screening.
- The participant has an anticipated change in exercise regimen or new exercise program during the course of the study.
See the full eligibility criteria
- Each participant must meet all the following criteria to be enrolled in this study:
- The participant is male or female, ≥18 years of age and of legal adult age in accordance with local requirements.
- The participant has a confirmed CPVT diagnosis, based on genetic screening for a pathogenic ryanodine receptor (RYR2) mutation and a clinical phenotype consistent with CPVT at Screening. Previous CPVT genetic testing...
- The participant can perform an EST during which frequent premature ventricular contractions (PVCs; ≥10 per minute), ventricular bigeminy, or higher-grade VA (equivalent to a VA score ≥2) are identified by the...
- The participant has been on a stable dose of at least 1 antiarrhythmic medication (including beta blockers but not amiodarone) for 4 weeks prior to Screening, unless the participant has been unable to tolerate...
- Adheres to all contraceptive criteria.
- Participants meeting any of the following criteria will be excluded from the study:
- The participant has clinically significant structural heart disease, diagnosis of heart failure, or clinically significant coronary artery disease.
- The participant has a clinically significant abnormal ECG not explained by the diagnosis of CPVT at Screening or clinically significant abnormal intervals, such as prolonged QT.
- The participant has a history of a myocardial infarction, cerebrovascular accident, or transient ischemic attack within 3 months of Screening.
- The participant undergoes implantable cardioverter-defibrillator (ICD) implantation or has sympathetic nerve denervation within 3 months of Screening.
- The participant has an anticipated change in exercise regimen or new exercise program during the course of the study.
- The participant has a history of malignancy within the past 5 years at Screening, with the exception of successfully treated basal cell carcinoma or nonmetastatic squamous cell carcinoma of the skin or cervical...
- The participant has abnormal blood pressure, defined as supine symptomatic hypotension, systolic blood pressure \>150 mm Hg or diastolic blood pressure \>90 mm Hg, or symptomatic bradycardia or a heart rate \>100 bpm at...
- The participant has hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 × (upper limit of normal [ULN]) and/or total bilirubin \>1.5 × ULN at Screening (unless secondary...
- The participant has acute or chronic hepatitis B (HBV; defined as hepatitis B surface antigen [HBsAg] reactive), acute or chronic hepatitis C virus (HCV; defined as detection of HCV antibody and RNA [qualitative]), or...
- The female participant is pregnant, lactating/breastfeeding, or has plans to become pregnant during the study or within 3 months following the last study drug administration.
- The participant has taken any antiarrhythmic drug in addition to their stable, chronic regimen unless it has been at least 5 half-lives since administration at the time of Screening.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Morrisville, North Carolina, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Madison, Wisconsin, United States
- Vancouver, British Columbia, Canada
- Bron, France
- Paris, France
- Saint-Herblain, France
- Pavia, Pavia, Italy
- Amsterdam, North Holland, Netherlands
- Esplugues de Llobregat, Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Morrisville, North Carolina, United States; Houston, Texas, United States; Salt Lake City, Utah, United States; Madison, Wisconsin, United States; Vancouver, British Columbia, Canada and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.