Influence of CYP2C19 Genetic Variants on Clopidogrel in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Inhibition platelet activity index (ADP induced aggregation) measured between
研究概览
简要总结
To test pharmacodynamic response to clopidogrel 150mg once daily during 7 days in healthy subjects carriers of a mutated allele (*2) associated with CYP2C19 deficiency and non responders to the usual regimen of 75 mg once daily
详细描述
Thirty individuals genotyped for specific variants of 2C19 cytochrome and P2Y12 platelet ADP receptor will receive during one week a daily dose of 75 mg of clopidogrel. Depending on their pharmacodynamic response to this dose of clopidogrel, subjects will be affiliated to two groups, "good responders" and "bad responders". After a wash-out period, "bad responders" will receive a double dose of clopidogrel, while the "good responders" will receive 75 mg of clopidogrel, associated with a CYP2C19 inhibitor. Such study will allow to evaluate both the impact of raising daily dose of clopidogrel in patients with defected variants of 2C19 and potential interactions of clopidogrel with other drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers, aged 18 to 35, non smoker, of caucasian origin
- •Compatible 2C19 and P2Y12 genotypes
- •Weight 60 kg to 100 kg, and normal BMI
- •Standard laboratory investigations normal
- •Negative testing for HIV infection and B and C hepatitis
- •Basal platelet agregation testing normal
- •EKG, blood pressure and cardiac frequency in normal range
- •Ability to understand, follow and sign the protocol
排除标准
- •Evolutive medical affection, even treated
- •Medical history of allergic response to medication or other, peptic ulcer, or known hemorrhagic disorder
- •Laboratory testing out of normal range
- •Subjects practicing violent sports
- •Unability to understand or follow the protocol
研究组 & 干预措施
1
Clopidogrel
干预措施: Clopidogrel (Drug)
2
Clopidogrel
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Inhibition platelet activity index (ADP induced aggregation) measured between
时间窗: during 7 days
次要结局
- Clopidogrel and metabolites pharmacokinetics and relation to dynamics(during 7 days)