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

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Celltrion Healthcare

Status and phase

Terminated
Phase 1

Conditions

Cardiomyopathy, Hypertrophic Obstructive

Treatments

Drug: Placebo
Drug: CT-G20

Study type

Interventional

Funder types

Industry

Identifiers

NCT04418297
CT-G20 1.2

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

23 participants in 2 patient groups, including a placebo group

CT-G20
Experimental group
Treatment:
Drug: CT-G20
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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