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

Cardurion Pharmaceuticals, Inc.

Summary

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.

Eligibility

Age range: 18–99 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: Each participant must meet all the following criteria to be enrolled in this study: 1. The participant is male or female, ≥18 years of age and of legal adult age in accordance with local requirements. 2. 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 documented in medical history is acceptable if confirmed by the Investigator and documented in the study source records. 3. The participant can perform an ES…

Interventions

Drug
CRD-4730
Oral CRD-4730 in tablet form
Drug
Placebo
Placebo to match CRD-4730 in tablet form

Locations (12)

Cardurion Investigative Site
San Francisco, California
Cardurion Investigative Site
Morrisville, North Carolina
Cardurion Investigative Site
Houston, Texas
Cardurion Investigative Site
Salt Lake City, Utah
Cardurion Investigative Site
Madison, Wisconsin
Cardurion Investigative Site
Vancouver, British Columbia