Effectiveness of CRD-4730 in Participants With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Megadott ok: 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.
A legfontosabb adatok
- Hol
- Cincinnati, Cleveland és Houston (Egyesült Államok)Mind a 3 helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- Cincinnati Children's Hospital Medical CenterCincinnati, Egyesült ÁllamokNo longer taking part
- Cleveland Clinic Children's HospitalCleveland, Egyesült ÁllamokNo longer taking part
- Baylor College of MedicineHouston, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Cardurion Pharmaceuticals, Inc.
- Azonosító
- NCT06005428EU 2022-502845-83-00
- A regiszteradat frissítve
- 2026. május 27.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
A Phase 2A, Investigator & Subject Blinded, Sponsor Unblinded, Placebo-Controlled, Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of CRD-4730 in Participants With Catecholaminergic Polymorphic Ventricular Tachycardia
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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; 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).