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Effectiveness of CRD-4730 in Participants With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

C

Cardurion Pharmaceuticals

Status and phase

Enrolling
Phase 2

Conditions

Heart Defects, Congenital
Heart Diseases
CPVT1
Ventricular Tachycardia

Treatments

Drug: Placebo
Drug: CRD-4730

Study type

Interventional

Funder types

Industry

Identifiers

NCT06005428
CRD-4730-201

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Males or Females ≥18 years of age, at screening.
  2. Confirmed CPVT diagnosis, based on genetic screening for a known RyR2 mutation and a clinical phenotype consistent with CPVT at screening.
  3. Ability to perform an Exercise Stress Test (EST) during which exercise-induced ventricular couplets or higher-grade VA (equivalent to a VA score ≥3) are identified by the investigator.
  4. Stable doses of any anti-arrhythmic medication, except amiodarone, for 4 weeks prior to screening.
  5. Adhere to all contraceptive criteria.

Exclusion criteria

  1. Clinically significant structural heart disease, diagnosis of heart failure, or clinically significant coronary artery disease.
  2. History of a myocardial infarction, cerebrovascular accident, or transient ischemic attack within 3 months of screening.
  3. 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).
  4. 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.
  5. Use of amiodarone with 3 months prior to screening. NOTE: other protocol defined Inclusion/ Exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

12 participants in 3 patient groups, including a placebo group

Dose 1
Experimental group
Description:
CRD-4730 Dose 1 capsule
Treatment:
Drug: CRD-4730
Dose 2
Experimental group
Description:
CRD-4730 Dose 2 capsule
Treatment:
Drug: CRD-4730
Dose 3
Placebo Comparator group
Description:
Placebo capsule to match CRD-4730
Treatment:
Drug: Placebo

Trial contacts and locations

12

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Central trial contact

Jason Homsy, M.D., Ph.D.

Data sourced from clinicaltrials.gov

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