NCT01487460已完成1 期
A First-in-human Randomized, Double-blind, Placebo-controlled, 4-part Study to Assess Safety, Tolerability, Pharmacokinetics (Including Open Label Study of Food Effect and Interaction With Simvastatin) and Pharmacodynamics of Interwoven Single- and Multiple-ascending Doses of TAP311 in Healthy Subjects and Dyslipidemic Patients.
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
- 137
- 试验地点
- 1
- 主要终点
- Safety and tolerability of single and multiple doses of TAP311 in healthy subjects and patients with dyslipidemia
研究概览
简要总结
This study will assess the safety, tolerability, and effect of TAP311 on blood lipids in healthy subjects and in patients who have dyslipidemia. The effect of food on TAP311 concentration in blood and effect of TAP311 administration on simvastatin concentration will also be assessed in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects age 18 to 65 years of age included, and in good health as determined by past medical history, physical examination, electrocardiogram, and laboratory tests at screening.
- •OR untreated dyslipidemic patients.
- •Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 36 kg/m
- •Able to communicate well with the investigator, to understand and comply with the requirements of the study.
排除标准
- •Use of other investigational drugs at the time of enrollment.
- •Active treatment for type 1 diabetes or type 2 diabetes mellitus.
- •A past medical history of ECG abnormalities, documented cardiac arrhythmias or cardiovascular diseases.
- •History of malignancy of any organ system, treated or untreated, within the past 5 years.
- •Pregnant or nursing (lactating) women.
- •Use of any prescription drugs, herbal supplements and/or over-the-counter (OTC) medication, dietary supplements.
- •History of drug or alcohol abuse within the 12 months prior to dosing.
- •Any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
TAP311 in Healthy Volunteers
Experimental
干预措施: TAP311 (Drug)
Matching Placebo
Placebo Comparator
Healthy Volunteers and Patients will be treated in Placebo group.
干预措施: TAP311 (Drug)
TAP311 and Simvastatin
Experimental
干预措施: TAP311 (Drug)
TAP311 in Patients
Experimental
干预措施: TAP311 (Drug)
结局指标
主要结局
Safety and tolerability of single and multiple doses of TAP311 in healthy subjects and patients with dyslipidemia
时间窗: Up to 21 days
Number of patients with adverse events and changes from baseline in vital signs, ECG and clinical labs (blood chemistry, hematology and urinalysis).
次要结局
- TAP311 concentrations in blood and urine following administration of single and multiple doses in healthy subjects and in patients with dyslipidemia.(25 timepoints over 17 days)
- Effect of TAP311 administration on simvastatin (and metabolite) blood concentration in healthy subjects.(10 days)
- Effect of food on TAP311 blood concentration in healthy subjects.(3 days)
- Effects of TAP311 on total cholesterol in patients with dyslipidemia(8 timepoints over 15 days)
- Effects of TAP311 on Low Density Lipoprotein (LDL-C) in patients with dyslipidemia(8 timepoints over 15 days)
- Effects of TAP311 on high density lipoprotein (HDL-C)in patients with dyslipidemia.(8 timepoints over 15 days)
- Effects of TAP311 on triglycerides in patients with Dyslipidemia(8 timepoints over 15 days)
研究者
研究点 (1)
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