ACTRN12611000303943已完成1 期
A Phase 1 Study to determine the effect of a high fat meal on the pharmacokinetics of Brivanib in Healthy Subjects.
Bristol-Myers Squibb Australia0 个研究点目标入组 20 人开始时间: 2011年3月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Healthy Men and Women aged 18-55 years inclusive.
- •Women who are not of child bearing potential
- •Body Mass Index of 18.0-30.0 kg/m2 inclusive
排除标准
- •Any significant acute or chronic illness.
- •Any clinically significant illness, laboratory findings or allergies.
- •History of hypertension (> 140/90 mmHg consistently on two separate measurements without treatment).
- •Inability to tolerate oral medication.
- •Inability to be repetitively venipunctured and/or tolerate venous access.
- •Any history of cardiovascular disease including congestive heart failure of any grade, thromboembolic disease, myocardial infarction, any angina, stroke, transient ischemic attack, or any other ischemic event or symptoms (eg,intermittent claudication).
- •Resting heart rate less than 45 beats per minute.
- •Resting blood pressure greater than 140/90 mmHg.
- •Any of the following on 12-lead ECG prior to study drug administration,confirmed by repeat:
- •i) PR greater than or equal to 210 millisecond (msec)
- •ii) QRS greater than or equal to 120 msec
- •iii) QT greater than or equal to 500 msec
- •iv) QTcF greater than or equal to 450 msec
- •Current use of tobacco (eg, smoker, chew) or recent history (within 1 month of screening) of regular tobacco use or a nicotine replacement product.
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