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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. Each participant will be randomized to one of the 3 sequences in which they will receive 2 different doses of CRD-4730 and 1 dose of matching placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental | CRD-4730 Dose 1 Tablet |
|
| Dose 2 | Experimental | CRD 4730 Dose 2 Tablet |
|
| Dose 3 | Placebo Comparator | Placebo tablet to match CRD-4730 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRD-4730 | Drug | Oral CRD-4730 in tablet form |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measures | The number and severity of treatment-emergent adverse events (TEAEs) related to study drug treatment | Baseline to Day 101 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome Measure | Change in VA score during EST from baseline to Day 15, from baseline to Day 44, and from baseline to Day 73 | Baseline to Day 15; Baseline to Day 44; Baseline to Day 73 |
| Secondary Outcome Measures |
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Inclusion Criteria:
Each participant must meet all the following criteria to be enrolled in this study:
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded from the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cardurion | Contact | 617-863-8088 | infoCPVT@cardurion.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardurion Investigative Site | Recruiting | San Francisco | California | 94143 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Takagahara, Shuichi, et al. "Novel, Potent, and Highly Selective Calcium/Calmodulin-Dependent Protein Kinase II (CaMKII) Inhibitors Reduce Substrate Phosphorylation in Rat Hearts and Prolong Survival in a Mouse Model of Severe Heart Failure." Circulation 148.Suppl_1 (2023): A12726-A12726. |
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| ID | Term |
|---|---|
| D000098850 | Polymorphic Catecholaminergic Ventricular Tachycardia |
| D017180 | Tachycardia, Ventricular |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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3-period randomized 3-sequence study
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Investigator, Subject, Outcomes Assessor, and Sponsor Blinded; placebo-controlled
| Placebo |
| Drug |
Placebo to match CRD-4730 in tablet form |
|
Plasma concentrations of CRD-4730 over time for each treatment period
| Baseline to Day 15; Baseline to Day 44; Baseline to Day 73 |
| Cardurion Investigative Site |
| Recruiting |
| Morrisville |
| North Carolina |
| 27560 |
| United States |
| Cardurion Investigative Site | Recruiting | Houston | Texas | 77030 | United States |
| Cardurion Investigative Site | Recruiting | Salt Lake City | Utah | 84113 | United States |
| Cardurion Investigative Site | Recruiting | Madison | Wisconsin | 53792 | United States |
| Cardurion Investigative Site | Recruiting | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Cardurion Investigative Site | Recruiting | Bron | 69677 | France |
| Cardurion Investigative Site | Recruiting | Paris | 75018 | France |
| Cardurion Investigative Site | Recruiting | Saint-Herblain | 44800 | France |
| Cardurion Investigative Site | Recruiting | Pavia | Pavia | 27100 | Italy |
| Cardurion Investigative Site | Recruiting | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Cardurion Investigative Site | Recruiting | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |