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A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy | Clinical Trials | Clareo Health

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A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy

A Randomized, Double-Blind, Placebo-Controlled, Sequential, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy

NCT04418297•Celltrion

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, placebo-controlled, sequential, 5-day treatment, ascending dose study in subjects with obstructive HCM aged 18-70 years. The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Men or women aged 18 to 70 years, inclusive at Screening
•2. Has established diagnosis of HCM defined by standard criteria as a maximal left ventricular wall thickness ≥15 mm at initial diagnosis in the absence of other causative loading abnormalities capable of producing the magnitude of hypertrophy observed or ≥13 mm if the subject has a family history of HCM
•3. Has LVOT gradient ≥30 mmHg at rest or LVOT gradient ≥50 mmHg with Valsalva maneuver, due to SAM

Exclusion Criteria

•1. Known infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics HCM, such as Fabry disease, amyloidosis or Noonan syndrome with LV hypertrophy
•2. History of persistent atrial fibrillation prior to Screening or Baseline
•3. History of paroxysmal atrial fibrillation requiring treatment (e.g., anti-coagulation and/or antiarrhythmic therapy) within 3 months prior to Screening
•4. Recently treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation) within 6 months prior to Screening or plans to have either of these treatments during the study
•5. Systolic heart failure with ejection fraction \<55% or heart failure symptoms of NYHA Class IV
•6. QTcF \>480 msec at Screening or Baseline
•7. Presence of diseases classified as significant by the Investigator at Screening or Baseline, including the following but not limited to:
•1. Diabetes mellitus requiring treatment
•2. Moderate or severe renal insufficiency or renal insufficiency with estimated glomerular filtration rate \<70 mL/min/1.73m2
•8. Concomitant use of Disopyramide or Ranolazine within at least 7 days or 5 half-lives (whichever is longer) prior to Screening

Locations (11)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Tufts Medical Center

Boston, Massachusetts, United States

New York University Langone Medical Center

New York, New York, United States

Independent Public Central Clinical Hospital

Warsaw, Masovian Voivodeship, Poland

Institute of Cardiology in Warsaw

Warsaw, Masovian Voivodeship, Poland

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Chonnam National University Hospital

Gwangju, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Key Dates

Start Date

October 23, 2020

Primary Completion Date

November 22, 2022

Completion Date

November 22, 2022

Last Updated

March 2, 2023

Enrollment

ACTUAL participants

Conditions

Cardiomyopathy, Hypertrophic Obstructive

Interventions

CT-G20

DRUG

Placebo

DRUG

A Phase 2 Open-label Pilot Study Evaluating MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

NCT02842242

Cardiomyopathy, Hypertrophic ObstructiveLeft Ventricular Outflow Tract Obstruction

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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