NCT01340456已完成不适用
Induction of Drug Metabolism by Rifampicin to Compare the Endogenous Biomarker 4beta-OHcholesterol With the Probe Drug Midazolam as Quantitative Markers for Cytochrome P450 3A4 Induction
Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2011年5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
- 24
- 试验地点
- 1
- 主要终点
- Change in 4beta-OHcholesterol
研究概览
简要总结
The objectives of this study are:
- To investigate if the endogenous cholesterol metabolite, 4beta-OHcholesterol could be used as a marker for induction of cytochrome P450 (CYP) 3A4.
- To compare 4beta-OHcholesterol with midazolam as a marker for induction of CYP3A4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females and males.
- •Age of 18 and above.
- •Caucasians.
- •Healthy as assessed by medical history and examination by principal investigator or delegated personnel.
- •Accept to refrain from herbal drugs, natural preparations, and grapefruit juice 48 hours before and during the study period.
- •Accept to completely refrain from alcohol during day -1 to 1 and R14-R
- •During the rest of the study moderate alcohol use is permitted (equal to 1 glass of wine or 1 beer per day).
- •Women of childbearing age should accept using a reliable barrier contraceptive method throughout the study.
- •Women of childbearing age should have a negative pregnancy test at the screening visit.
- •Capable of following given instructions.
- •Has given written informed consent after receiving both oral and written study information.
排除标准
- •Predisposal to allergic drug reactions.
- •Anamnestic and/or visual signs of infection.
- •Women are not allowed to use oral hormone-based contraceptives 2 weeks before start of study and during the study.
- •Participation in another study within one month before entering the present study.
- •Intake of any other drug that can influence the enzyme activity of CYP3A
- •Breast-feeding.
- •A history of liver disease.
研究组 & 干预措施
Rifampicin 10 mg QD
Experimental
干预措施: Rifampicin treatment (Drug)
Rifampicin 20 mg QD
Experimental
干预措施: Rifampicin treatment (Drug)
Rifampicin 100 mg QD
Experimental
干预措施: Rifampicin treatment (Drug)
结局指标
主要结局
Change in 4beta-OHcholesterol
时间窗: Directly before treatment with rifampicin and 14 days after the end of treatment with rifampicin
The primary objective of the study is to investigate whether the endogenous cholesterol metabolite 4β-hydroxycholesterol could be used as a marker for induction of CYP3A4. For this purpose the induction of 4β-hydroxycholesterol formation will be compared to the induction of quinine and midazolam metabolism.
次要结局
- Ratio between midazolam AUC induced and midazolam AUC uninduced(Before treatment with rifampicin and after 14 days of treatment with rifampicin)
研究者
研究点 (1)
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