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

Cardiomyopathy, Hypertrophic Obstructive Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Sequential, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04418297
• Other study ID #: CT-G20 1.2
• Status: Terminated
• Phase: Phase 1
• Start date: October 23, 2020
• Est. completion date: November 22, 2022

Study information

• Verified date: August 2022
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: November 22, 2022
• Est. primary completion date: November 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Cardiomyopathy, Hypertrophic Obstructive
• Hypertrophy

Intervention

Drug:
• CT-G20
oral tablet
• Placebo
oral tablet

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Poland	Independent Public Central Clinical Hospital	Warsaw	Mazowieckie
Poland	Institute of Cardiology in Warsaw	Warsaw	Mazowieckie
United States	Tufts Medical Center	Boston	Massachusetts
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	New York University Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of treatment-emergent adverse events and their relationship to the investigational product		12 days