NCT01311362已完成不适用
Influence of CYP3A4-induction by St. John's Wort (SJW) on the Steady State Pharmacokinetics of Ambrisentan
Gerd Mikus1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- AUC of Ambrisentan
研究概览
简要总结
The aim of the present study is to assess the impact of CYP3A4-induction by SJW on steady state ambrisentan and the impact of the cytochrome P450 2C19 (CYP2C19) genotype (*2 and *3 allele vs. wild type; ~2-5% poor metabolisers in Caucasian population) on the pharmacokinetics of ambrisentan in healthy volunteers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good state of health (physically and mentally)
- •Able to communicate well with the investigator, to understand and comply with the requirements of the study
- •Voluntarily signed informed consent after full explanation of the study to the participant.
- •No clinically relevant findings in any of the investigations of the pre-study examination, especially aminotransferase elevations ≥ 3 × upper limit of normal (ULN). Minor deviations of other laboratory values from normal range may be acceptable, if judged by the investigator to be of no clinical relevance.
- •Known genotype for CYP2C19 polymorphism.
- •Agreement to abstain from alcoholic beverages during the time of the study.
- •Females must agree to use a reliable contraception (Pearl Index <1%), e.g. double barrier method.
排除标准
- •Any regular drug treatment within the last two months, except for oral contraceptives in female volunteers and L-thyroxine.
- •Any intake of a substance known to induce or inhibit drug metabolising enzymes or drug transporters within a period of less than 10 times the respective elimination half-life or 2 weeks, whatever is longer
- •Any participation in a clinical trial within the last month before inclusion
- •Any physical disorder which could interfere with the participant's safety during the clinical trial or with the study objectives
- •Any acute or chronic illness, or clinically relevant findings in the pre-study examination, especially: a) any condition, which could modify absorption, distribution, metabolism, or excretion of the drug regimen under investigation b) Allergies (except for mild forms of hay fever) or history of hypersensitivity reactions
- •Regular smoking
- •Blood donation within 6 weeks before first study day
- •Excessive alcohol drinking (more than approximately 20 g alcohol per day)
- •Inability to communicate well with the investigator due to language problems or poor mental development
- •Inability or unwillingness to give written informed consent
- •Known or planned pregnancy or breast feeding
- •Pre-existing moderate or severe liver impairment
- •Contraindication against midazolam, ambrisentan, or SJW or any known intolerance to any of these substances or their additives
研究组 & 干预措施
CYP2C19 wild type
CYP2C19 wild type ="extensive metaboliser"
- Administration of ambrisentan: 5 mg p.o. q.d. on day 1 and days 3-20
- Administration of St. Johns wort: 300 mg p.o. three times a day (t.i.d.) on days 11-20
干预措施: St. Johns wort (Drug)
CYP2C19 mutant
CYP2C19 *2/*2 or *2/*3 or *3/*3 = "poor metaboliser"
- Administration of ambrisentan: 5 mg p.o. q.d. on day 1 and days 3-20
- Administration of St. Johns wort: 300 mg p.o. three times a day (t.i.d.) on days 11-20
干预措施: St. Johns wort (Drug)
结局指标
主要结局
AUC of Ambrisentan
时间窗: after first dose, at steady-state, during St John's wort
Cmax of Ambrisentan
时间窗: after first dose, at steady-state and during St John's wort
次要结局
未报告次要终点
研究者
Gerd Mikus
Head of Clinical Research Unit
Heidelberg University
研究点 (1)
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