A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Celltrion
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy
