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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
12
Cardurion Investigative Site
San Francisco, California, United States
RECRUITINGCardurion Investigative Site
Morrisville, North Carolina, United States
RECRUITINGCardurion Investigative Site
Houston, Texas, United States
Primary Outcome Measures
The number and severity of treatment-emergent adverse events (TEAEs) related to study drug treatment
Time frame: Baseline to Day 101
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
Time frame: Baseline to Day 15; Baseline to Day 44; Baseline to Day 73
Secondary Outcome Measures
Plasma concentrations of CRD-4730 over time for each treatment period
Time frame: Baseline to Day 15; Baseline to Day 44; Baseline to Day 73
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Cardurion Investigative Site
Madison, Wisconsin, United States
RECRUITINGCardurion Investigative Site
Saint-Herblain, France
RECRUITINGCardurion Investigative Site
Pavia, Pavia, Italy
RECRUITINGCardurion Investigative Site
Amsterdam, North Holland, Netherlands
RECRUITINGCardurion Investigative Site
Esplugues de Llobregat, Barcelona, Spain
RECRUITING