NCT01679639已完成1 期
An Open-label, Fixed-sequence, Three-period, Single Group Study to Investigate the Effects of Rifampicin as an OATP1B1 Inhibitor and a CYP2C8 Inducer on the Pharmacokinetics of Aleglitazar in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Pharmacokinetics: Area under the plasma concentration time curve
研究概览
简要总结
This open-label, fixed-sequence, three-period, single group study will evaluate the effects of rifampicin on the pharmacokinetics of aleglitazar in healthy volunteers. Volunteers will receive single doses of aleglitazar in all three periods and single doses of rifampicin in periods 1 and 2, and multiple doses in period 3. The anticipated time on study treatment is up to 14 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers, aged 18 to 55 years inclusive at the time of screening
- •Body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive
- •Females must be surgically sterile or use two acceptable methods of contraception
- •Non-smoker or currently smoking less than five cigarettes/day and willing to abstain from smoking during the study
排除标准
- •Any clinically relevant abnormal laboratory test results at screening or on Day -1 of all periods, as judged by the Investigator
- •A history of clinically significant disorders (e.g., gastro-intestinal, cardiovascular, hepatic)
- •Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- •An average alcohol intake of more than 14 units per week
- •Volunteers diagnosed, or suspected of having porphyria, and subjects with first degree relatives diagnosed, or suspected of having porphyria
- •Diagnosis of Gilberts Syndrome
- •A positive screen for drugs of abuse at screening or on admission to the clinical unit
研究组 & 干预措施
Aleglitazar
Experimental
干预措施: aleglitazar (Drug)
Aleglitazar
Experimental
干预措施: rifampicin (Drug)
结局指标
主要结局
Pharmacokinetics: Area under the plasma concentration time curve
时间窗: Period 1 and 2: Predose and days 1 to 5; Period 3: Days 5 to 12
次要结局
- Safety: incidence of adverse events(14 weeks)
研究者
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