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The termination criteria of the protocol was met during dose escalation
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-G20 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-G20 | Drug | oral tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events and their relationship to the investigational product | 12 days |
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Inclusion Criteria:
Exclusion Criteria:
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:
Concomitant use of Disopyramide or Ranolazine within at least 7 days or 5 half-lives (whichever is longer) prior to Screening
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Tufts Medical Center |
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| Drug |
oral tablet |
|
| Boston |
| Massachusetts |
| 02111 |
| United States |
| New York University Langone Medical Center | New York | New York | 10016 | United States |
| Independent Public Central Clinical Hospital | Warsaw | Masovian Voivodeship | 02097 | Poland |
| Institute of Cardiology in Warsaw | Warsaw | Masovian Voivodeship | 04628 | Poland |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Chonnam National University Hospital | Gwangju | 61469 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Chung-Ang University Hospital | Seoul | 06973 | South Korea |
| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
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