NCT00551317已完成1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of Darapladib (SB480848) in Healthy Japanese Male Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- - Safety/tolerability of single oral doses of darapladib
研究概览
简要总结
This study is being conducted to provide initial safety, tolerability, PK and PD data that will allow further studies with darapladib in Japanese patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Japanese males, 20-64 years of age, inclusive
- •Body weight >50Kg
- •Body Mass Index (BMI): 18-28
- •Subjects must have lived outside of Japan no more than 10 years
- •Non-smoker or smokes fewer than 10 cigarettes/day
排除标准
- •History of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses
- •History of sensitivity to heparin or heparin-induced thrombocytopenia
- •History of alcohol/drug abuse or dependence within 12 months of the study
- •Positive syphilis, HIV antibody, Hepatitis B, Hepatitis C
- •History of cholecystectomy or biliary tract disease or history of liver disease
- •Participation in a clinical study within 30 days prior to first dose
- •Subject has been exposed to more than 4 chemical entities within 12 months
- •Positive urine drug and alcohol at screening
- •Subject has any medical history or clinically relevant abnormality that would make the subject ineligible for inclusion due to safety reasons.
结局指标
主要结局
- Safety/tolerability of single oral doses of darapladib
时间窗: 4, 24 and 96h post-dose
- Primary Pharmacokinetic parameters of single oral doses of darapladib
时间窗: pre-dose, 0,5, 1, 2, 3, 4, 6, 9 12, 16, 24, 48, 72h post-dose
次要结局
- -Secondary PK parameters -PK parameters of SB553253 -inhibition of Lp-PLA2 activity -description of plasma concentration-Lp-PLA2 activity inhibition relationship after single oral doses of darapladib. all measured same timepoints as primary PK(Throughout the study)
研究者
研究点 (1)
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