NCT00892840已完成1 期
Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-820836 in Healthy Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of BMS-820836 following multiple-dose administration
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of BMS-820836 after multiple doses
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Panels 1-6: Healthy Male Subjects
- •Panel 7: Females
- •Ages 21 to 55, inclusive
- •Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive
- •Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
排除标准
- •Any major surgery within 4 weeks of study drug administration
- •History of cholecystectomy
- •History of glaucoma or a confirmed intraocular pressure indicative of glaucoma at screening. (Normal IOP <21 mmHg)
- •Confirmed QTc (Fridericia) value ≥ 450 msec
- •Confirmed QT ≥ 500 msec
- •Confirmed PR ≥ 210 msec
- •Confirmed QRS ≥ 120 msec
- •Confirmed resting supine systolic blood pressure > 140 mmHg
- •Confirmed resting supine diastolic blood pressure > 90 mmHg
- •Confirmed resting heart rate < 45 bpm or > 100 bpm
- •Orthostatic vital sign changes (ie., a decrease in systolic blood pressure from supine to standing > 40 mmHg and an increase in heart rate from supine to standing > 20 bpm) or symptoms of orthostasis
- •History of peppermint allergies
- •Exposure to any investigational drug or placebo within 12 weeks of study drug administration
研究组 & 干预措施
Panels 1 to 7 (BMS-820836 or Placebo)
Experimental
干预措施: BMS-820836 (Drug)
Panels 1 to 7 (BMS-820836 or Placebo)
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the safety and tolerability of BMS-820836 following multiple-dose administration
时间窗: Within 27 days (+/- 2 days) of first dose
次要结局
- To assess the pharmacodynamics of BMS-820836(Within 27 days of first dose)
研究者
研究点 (1)
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