The purpose of this study is to assess the safety and to examine the index of the efficacy after repeated dosing of CNT-01 in patients with idiopathic triglyceride deposit cardiomyovasculopathy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
After being informed about the study and potential risks, all patients giving written informed consent undergo screening tests to determine eligibility for study enrollment. On Day 1, patients who meet the eligibility criteria will start taking CNT-01 500mg orally three times daily for 14 days. On Day 15, patients will take CNT-01 500 mg only once after blood drawing.
Cardiovascular Medicine, Osaka University Hospital
Suita, Osaka, Japan
Number of adverse event
Time frame: Baseline to Day 29
Change in 12-lead ECG recordings from Baseline
Time frame: Baseline to Day 29
Change in Blood Pressure from Baseline
Time frame: Baseline to Day 29
Change in clinical laboratory testings as measured by serum chemistry, hematology and urinalysis from Baseline (composite)
Time frame: Baseline to Day 29
Change in Body temperature from Baseline
Time frame: Baseline to Day 29
Change in Pulse rate from Baseline
Time frame: Baseline to Day 29
Change in uptake and washout rate in BMIPP myocardial scintigraphy
Time frame: Baseline to Day 15
Change in blood concentration of fatty acid fraction from Baseline (Octanoic acid, Capric acid, Myristic acid, Palmitic acid and Stearic acid)
Time frame: Baseline to Day 16
Change in lipase activity in peripheral polynuclear leucocyte from Baseline
Time frame: Baseline to Day 29
Change in blood lipoprotein fraction from Baseline
Time frame: Baseline to Day 29
Change in vacuolation rate in polynuclear leucocyte from Baseline
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Time frame: Baseline to Day 29
Change in frequency in use of nitroglycerin from Baseline
Time frame: Baseline to Day 29
Change in New York Heart Association (NYHA) functional classification from Baseline
Time frame: Baseline to Day 29
Change in reactive hyperemic index from Baseline
Time frame: Baseline to Day 29
Change in score of SF-36 from Baseline
Time frame: Baseline to Day 29