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Multiple ascending dose Phase I study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of CT-G20 in subjects with hypertrophic obstructive cardiomyopathy.


Title A Randomized, Double-Blind, Placebo-Controlled, Sequential, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CT-G20 in Subjects with Hypertrophic Obstructive Cardiomyopathy
Therapeutic Area Hypertrophic Cardiomyopathy
Principal Investigator Ethan Rowin, MD
Min Age 18 Years
Max Age 70 Years
Gender Any
Contact Daniel Higgins/Gaurav Das
617-636-4928
dhiggins@tuftsmedicalcenter.org / gdas@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04418297

Overview

This will be a double-blinded, placebo-controlled study, aiming to assess the safety and tolerability of CT-G20 in subjects with obstructive hypertrophic cardiomyopathy (oHCM).

Study Details

Inclusion Criteria

  • Subject 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.
  •  Subject has a left ventricular outflow tract (LVOT) gradient ≥30 mmHg at rest, or LVOT gradient ≥50 mmHg with Valsalva maneuver, due to SAM (systolic anterior motion) at Screening and Baseline.
  • Subject has documented left ventricular ejection fraction (LVEF) ≥55% at Screening and Baseline.

Exclusion Criteria

  • History of clinically significant allergic reactions (spontaneous, atopic allergy, or following drug administration) such as asthma, urticaria, angioedema, and eczematous dermatitis, hypersensitivity, also including known or suspected clinically relevant drug hypersensitivity to any components of IMP formulation or other similar drugs.
  • Presence of narrow-angle glaucoma.
  • Presence of galactose intolerance, Lapp lactase deficiency, or glucose or galactose malabsorption syndrome.

Study Requirements

We expect that you will be in this research study for a maximum of 5 weeks. You will be asked to come to the study site for a maximum of 3 weeks for screening, 5 days of in‑patient stay; 2 days of out-patient visits; and 1 week of EOS follow up. A total of 220 mL (approx. 15 tablespoons) of blood will be collected during the study period for each study group.