NCT02329405已完成4 期
PXR-aktivaation Vaikutus Maksan Rasvoittumiseen
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Hepatic fat fraction
研究概览
简要总结
This study investigates the effects of pregnane X receptor (PXR) activation on hepatic fat content in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR activator) and placebo will be given for a week to volunteers. Hepatic fat content is measured with magnetic resonance imaging and blood samples are collected at the end of each study arm. The investigators' hypothesis is that rifampicin causes accumulation of fat to the liver.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Body mass index (BMI) 18.5-25 kg/m2
排除标准
- •Systolic blood pressure over 150 mmHg
- •Any continuous medication (hormonal intrauterine device is permitted)
- •Any significant medical condition
- •Insensitivity to rifampicin
- •Pregnancy and lactation
- •Previous difficult venipuncture
- •Alcohol and medicine abuse and drug use
- •Participation to any other pharmaceutical trial within on month of screening
- •Claustrophobia
- •Metal and other implants which are contraindications to MRI
研究组 & 干预措施
Rifampicin
Experimental
Rifampicin 600 mg tablet once a day orally for a week.
干预措施: Rifampicin (Drug)
Placebo
Placebo Comparator
Placebo tablet once a day orally for a week.
干预措施: Placebo (Drug)
结局指标
主要结局
Hepatic fat fraction
时间窗: Day 8
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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