A PHASE 2A, INVESTIGATOR AND SUBJECT BLINDED, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CRD-4730 IN PARTICIPANTS WITH CATECHOLAMINERGIC POLYMORPHIC VENTRICULAR TACHYCARDIA - CRD-4730-201

Cardurion Pharmaceuticals Inc.0 个研究点目标入组 14 人开始时间: 2023年11月22日最近更新: 2024年7月22日

试验速览

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•The participant is male or female =18 years of age, The participant has a confirmed CPVT diagnosis, based on genetic screening for a known 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 exercise-induced ventricular couplets or higher-grade VA (equivalent to a VA score =3) are identified by the investigator. Please refer to the complete VA scoring system, as described in Section 8.4.2., The participant has been on a stable dose of any anti-arrhythmic medication, except amiodarone, for 4 weeks prior to Screening., The patient must be willing to adhere to all contraceptive requirements.

•The participant has clinically significant structural heart disease, diagnosis of heart failure, or clinically significant coronary artery disease., The participant has a history of a myocardial infarction, cerebrovascular accident, or transient ischemic attack within 3 months of Screening., The participant has a history of malignancy within the past 5 years at Screening, with the exception of successfully treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ., The female participant is pregnant, lactating/breastfeeding, or has plans to become pregnant during the study or within 3 months following the last study drug administration., Use of amiodarone with 3 months prior to screening. NOTE: other protocol defined Inclusion/ Exclusion criteria may apply.

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