NCT01632358已完成1 期
A Randomized, Double-blind, Placebo Controlled, Crossover Study to Assess Safety and Tolerability, Pharmacokinetics, and Explore Pharmacodynamics of TAP311 in Patients With Mixed Dyslipidaemia
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
- 279
- 试验地点
- 1
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
The study will assess the safety, tolerability and pharmacokinetics of TAP311 in patients with dyslipidemia.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients 18 to 80 years (inclusive) of age.
- •Patients are not treated for dyslipidemia with medications other than HMG-CoA reductase inhibitors (statins) for at least 4 weeks prior to Day
- •Patients should be on stable doses of current medications, if any, for at least 3 months to be eligible.
- •Patients must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 40 kg/m2.
排除标准
- •Use of other investigational drugs at the time of enrollment
- •History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- •Use of lipid modifying agents (e.g. fenofibrate, niacin, omega-3 fatty acids, etc.) other than statins will exclude subjects.
- •Pregnant or nursing (lactating) women
- •Diabetic patients whose plasma glucose is not well controlled by stable diabetic treatment for at least 3 months
- •Heavy smokers (smoke more than 10 cigarettes a day routinely and who cannot refrain from smoking during the study).
- •Women of child-bearing potential (WOCBP) can be included but must use highly effective contraception
- •Significant illness within two (2) weeks prior to initial dosing
- •History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- •A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
研究组 & 干预措施
TAP311 capsules
Experimental
Patients will receive TAP311 capsule orally once daily for 14 days.
干预措施: TAP311 capsules (Drug)
Placebo of TAP311 capsules
Placebo Comparator
Matching placebo to TAP311 capsule, once daily for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients with adverse events
时间窗: 14 days after treatment
Summary statistics on number of patients with total adverse events, serious adverse events and death will be reported.
次要结局
- Pharmacokinetics of TAP311: The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)(Day 1)
- Pharmacokinetics of TAP311: The Racc ratio from the plasma concentration-time data(Day 14)
- Pharmacokinetics of TAP311: The AUCtau, from the plasma concentration-time data(Day 14)
- Pharmacokinetics of TAP311: The observed maximum plasma concentration following drug administration at steady state (Cmax,ss)(Day 1 and Day 14)
- Pharmacokinetics of TAP311: The time to reach the maximum concentration after drug administration at steady state(Tmax, ss)(Day 1 and Day 14 profile)
研究者
研究点 (1)
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