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

NCT04418297 | Terminated Phase 1 FDA Drug

• 1 other identifier: CT-G20 1.2
• Study Type: interventional
• Target: 23
• Locations: 3 countries
• Sites: 11

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

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of treatment-emergent adverse events and their relationship to the investigational product

  12 days

Study Arms (2)

CT-G20

EXPERIMENTAL

Drug: CT-G20

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CT-G20 DRUG

oral tablet

CT-G20

Placebo DRUG

oral tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged 18 to 70 years, inclusive at Screening
• 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
• Has LVOT gradient ≥30 mmHg at rest or LVOT gradient ≥50 mmHg with Valsalva maneuver, due to SAM

You may not qualify if:

• 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:
• Diabetes mellitus requiring treatment
• Moderate or severe renal insufficiency or renal insufficiency with estimated glomerular filtration rate \<70 mL/min/1.73m2
• Concomitant use of Disopyramide or Ranolazine within at least 7 days or 5 half-lives (whichever is longer) prior to Screening

Sponsors & Collaborators

• Celltrion: lead

Study Sites (11)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Independent Public Central Clinical Hospital

Warsaw, Masovian Voivodeship, 02097, Poland

Location

Institute of Cardiology in Warsaw

Warsaw, Masovian Voivodeship, 04628, Poland

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Chung-Ang University Hospital

Seoul, 06973, South Korea

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 5, 2020
• Study Start: October 23, 2020
• Primary Completion: November 22, 2022
• Study Completion: November 22, 2022
• Last Updated: March 2, 2023

Record last verified: 2022-08

Locations

US (3); PL (2); KR (6)