Effectiveness of CRD-4730 in Participants With Catecholaminergic Polymorphic Ventricular Tachycar… (NCT06005428) | Clinical Trial Compass
TerminatedPhase 2
Effectiveness of CRD-4730 in Participants With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Stopped: The early termination of the clinical trial is due to an internal administrative and business decision, the study is not being terminated for safety reasons.
United States, Canada7 participantsStarted 2023-11-07
Plain-language summary
This is a Phase 2, multicenter, double-blind, sponsor unblinded, placebo-controlled, single-dose clinical study of CRD-4730 to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CRD-4730 when administered as single oral doses to participants with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). The study will have 2 cohorts in which participants with CPVT will participate in a 3-period, randomized 2-sequence study. Each participant will receive 2 different doses of CRD-4730 and 1 dose of matching placebo, with each study drug administered as a single dose.
Who can participate
Age range18 Years – 99 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Males or Females ≥18 years of age, at screening.
✓. Confirmed CPVT diagnosis, based on genetic screening for a known RyR2 mutation and a clinical phenotype consistent with CPVT at screening.
✓. The participant can perform an EST during which frequent premature ventricular contraction (PVCs) (≥10 per minute), ventricular bigeminy, or higher-grade VA (equivalent to a VA score ≥2) are identified by the investigator.
✓. Stable doses of any anti-arrhythmic medication, except amiodarone, for 4 weeks prior to screening.
✓. Adhere to all contraceptive criteria.
Exclusion criteria
✕. Clinically significant structural heart disease, diagnosis of heart failure, or clinically significant coronary artery disease.
✕. History of a myocardial infarction, cerebrovascular accident, or transient ischemic attack within 3 months of screening.
✕. History of malignancy within the past 5 years at screening (except successfully treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ).
What they're measuring
1
Treatment Emergent Adverse Events (TEAEs)
Timeframe: Baseline to Day 22
2
Changes in Laboratory Assessments
Timeframe: Baseline to Day 15
3
Changes in Vital Signs Measurement: Systolic and Diastolic blood pressure
Timeframe: Baseline to Day 15
4
Changes in Vital Signs Measurement: Pulse Rate
Timeframe: Baseline to Day 15
5
Changes in Vital Signs Measurement: Respiratory Rate
Timeframe: Baseline to Day 15
6
Changes in Vital Signs Measurement: Body Temperature
✕. Female participant that is pregnant or lactating/ breastfeeding, or has plans to do so during the study or within 3 months following last dose of study drug.
✕. Use of amiodarone with 3 months prior to screening. NOTE: other protocol defined Inclusion/ Exclusion criteria may apply.