A Phase 2 Study of CRD-4730 in CPVT
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorCardurion Pharmaceuticals, Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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 documented in medical history is acceptable if confirmed by the Investigator and documented in the study source records.
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 Investigator.
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 antiarrhythmic therapy previously.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
CRD-4730
DrugOral CRD-4730 in tablet form
Placebo
DrugPlacebo to match CRD-4730 in tablet form
Treatment groups
12 Participants
are divided into 3 treatment groupsGroup A: Dose 1Experimental treatment 1 intervention
Group B: Dose 2Experimental treatment 1 intervention
Group C: Dose 3Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary Outcome Measures
The number and severity of treatment-emergent adverse events (TEAEs) related to study drug treatment
Time frame
Baseline to Day 101Secondary outcomes
1
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 732
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 73Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov