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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Cardiomyopathy, Hypertrophic Obstructive

In brief

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.

Key facts

Study ID

NCT04418297

Run by

Celltrion

People needed

23

Starts

2020-10-23

Expected to finish

2022-11-22

Last updated by the study team

2023-03-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women aged 18 to 70 years, inclusive at Screening
• 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
• Has LVOT gradient ≥30 mmHg at rest or LVOT gradient ≥50 mmHg with Valsalva maneuver, due to SAM

You may not qualify if…

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

Where it is running

• 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
• Chung-Ang University Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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