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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-07

Study Completion Date

2025-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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CPVT1 Heart Defects, Congenital Heart Diseases Ventricular Tachycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

3-period randomized 2-sequence study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Investigator and Subject Blinded, Sponsor Unblinded; Placebo-controlled

Study Groups

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Dose 1

CRD-4730 Dose 1 capsule

Group Type EXPERIMENTAL

CRD-4730

Intervention Type DRUG

Oral CRD-4730 in capsule form

Dose 2

CRD-4730 Dose 2 capsule

Group Type EXPERIMENTAL

CRD-4730

Intervention Type DRUG

Oral CRD-4730 in capsule form

Dose 3

Placebo capsule to match CRD-4730

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match CRD-4730 in capsule form

Interventions

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CRD-4730

Oral CRD-4730 in capsule form

Intervention Type DRUG

Placebo

Placebo to match CRD-4730 in capsule form

Intervention Type DRUG

Eligibility Criteria

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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. 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.
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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No