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

NCT ID: NCT04418297

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-23
• Study Completion Date: 2022-11-22

Brief 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.

Conditions

Cardiomyopathy, Hypertrophic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CT-G20

Group Type: EXPERIMENTAL

CT-G20

Intervention Type: DRUG

oral tablet

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral tablet

Interventions

CT-G20

oral tablet

Intervention Type: DRUG

Placebo

oral tablet

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celltrion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States; Poland; South Korea

Other Identifiers

CT-G20 1.2

Identifier Type: -

Identifier Source: org_study_id