NCT02174250已完成1 期
Effect of a Strong Enzyme Inducer, Rifampin, on the Single-Dose Pharmacokinetics of Istradefylline 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
- 20
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve from time zero to infinity (AUC0 ∞) and Observed maximum plasma concentration (Cmax) of istradefylline
研究概览
简要总结
The purpose of this study is to test whether Rifampin affects blood levels of istradefylline in humans. Rifampin could possibly decrease istradefylline levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy non-smoking male and post-menopausal female subjects
- •Body Mass Index: 18.0-35.0 kg/m2, inclusive
- •Subjects must not be taking drugs that are moderate to potent inhibitors of CYP3A4 or CYP1A
- •Subjects without clinically significant medical history in the judgment of the investigator
- •Subjects without clinically significant laboratory or ECG abnormalities
排除标准
- •Females that are pregnant or lactating
- •Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study;
- •Known history of treatment for drug or alcohol addiction within the previous 12 months;
- •Subjects with an average alcohol intake of more than 2 units per day or 14 units per week up to 48 hours prior to the istradefylline dose on Day
- •One unit of alcohol is ½ pint of beer (285 mL) or 1 glass of spirits (25 mL) or 1 glass of wine (125 mL);
- •Donated or lost > 500 mL of blood within 3 months prior to istradefylline dose on Day 1 of Period 1;
- •Positive test results for human immunodeficiency virus (HIV) or Hepatitis B surface antigen, or Hepatitis C;
- •Positive test results for drugs of abuse at screening;
- •Unable, or unwilling to tolerate multiple venipunctures;
- •Difficulty fasting or eating the standard meals that will be provided;
- •Use of tobacco or nicotine-containing products within 90 days of the study start to the Follow-up visit
研究组 & 干预措施
Istradefylline 40mg
Experimental
Period 1: Day 1, istradefylline 40mg then crossover to Period 2
干预措施: Istradefylline 40 mg (Drug)
Rifampin 300mg BID + istradefylline 40mg
Experimental
Period 2: Days 1-20 rifampin 300mg BID + istradefylline 40mg Day 8 only
干预措施: Istradefylline 40 mg (Drug)
Rifampin 300mg BID + istradefylline 40mg
Experimental
Period 2: Days 1-20 rifampin 300mg BID + istradefylline 40mg Day 8 only
干预措施: Rifampin 300mg BID + istradefylline 40mg Day 8 only (Drug)
结局指标
主要结局
Area under the concentration-time curve from time zero to infinity (AUC0 ∞) and Observed maximum plasma concentration (Cmax) of istradefylline
时间窗: Intermittently for a total of 62 days
次要结局
- Number of serious adverse events, and non-serious adverse events(Continuously for up to 74 days)
研究者
研究点 (1)
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