NCT02502578已完成1 期
Phase I/IIa Study of CNT-01 in Patients With Idiopathic Triglyceride Deposit
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in Blood Pressure from Baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a definite diagnosis of idiopathic triglyceride deposit cardiomyovasculopathy
- •After receiving a sufficient explanation upon participation in this study, on a full understanding, patients who obtained the written informed consent from each patient
- •More than 20 years old at the time of informed consent
- •Is able to oral intake
- •Must be willing to comply with protocol-required examination such as BMIPP myocardial scintigraphy
排除标准
- •Have diabetic ketoacidosis
- •Have a malignancy that is being treated by anticancer drug or anticipated survival is less than three years
- •Female with pregnant or lactating
- •Is not able to agree to using intrauterine device, oral contraceptive, condom or having sexual intercourse from the start of taking investigational product to 30 days after the end of the study
- •Have a New York Heart Association functional classification IV
- •Have a known history of drug dependence
- •Is allergic to any component of the investigational product
- •Is allergic to BMIPP or iodine
- •Have a known history of clinically significant drug allergy
- •Have a severe liver dysfunction (Child classification B and C)
- •Participated in other clinical study within the past 3 months and received an investigational agent including placebo
- •Being treated with diet containing medium chain fatty acid
- •Is considered unfit for the study by the Investigator's medical decision
研究组 & 干预措施
CNT-01
Experimental
Patients will receive CNT-01 500 mg orally three times daily for 14 days. On Day 15, patients will take CNT-01 500 mg only once after blood drawing.
干预措施: CNT-01 500 mg capsule (Drug)
结局指标
主要结局
Change in Blood Pressure from Baseline
时间窗: Baseline to Day 29
Number of adverse event
时间窗: Baseline to Day 29
Change in 12-lead ECG recordings from Baseline
时间窗: Baseline to Day 29
Change in clinical laboratory testings as measured by serum chemistry, hematology and urinalysis from Baseline (composite)
时间窗: Baseline to Day 29
Change in Body temperature from Baseline
时间窗: Baseline to Day 29
Change in Pulse rate from Baseline
时间窗: Baseline to Day 29
次要结局
- Change in lipase activity in peripheral polynuclear leucocyte from Baseline(Baseline to Day 29)
- Change in New York Heart Association (NYHA) functional classification from Baseline(Baseline to Day 29)
- Change in reactive hyperemic index from Baseline(Baseline to Day 29)
- Change in blood lipoprotein fraction from Baseline(Baseline to Day 29)
- Change in vacuolation rate in polynuclear leucocyte from Baseline(Baseline to Day 29)
- Change in frequency in use of nitroglycerin from Baseline(Baseline to Day 29)
- Change in uptake and washout rate in BMIPP myocardial scintigraphy(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)(Baseline to Day 16)
- Change in score of SF-36 from Baseline(Baseline to Day 29)
研究者
Ken-ichi Hirano
Assistant Professor
Osaka University
研究点 (1)
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