NCT00949767已完成1 期
Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-866949 in Healthy Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2009年7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
- 64
- 试验地点
- 1
- 主要终点
- Primary endpoint is safety and tolerability evaluated by VS, ECG, clinical lab assessments and AEs
研究概览
简要总结
The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics of ascending single doses of BMS-866949 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 male 18-55
- •Women not of child bearing potential, 18-55
排除标准
- •History of or current treatment for psychiatric illnesses, substance abuse or dependence
- •History of a clinically significant neurological disorder (e.g., history of stroke, head trauma, etc.)
研究组 & 干预措施
BMS-866949 (Panel 1)
Experimental
干预措施: BMS-866949 (Drug)
BMS-866949 (Panel 1)
Experimental
干预措施: Placebo (Drug)
BMS-866949 (Panel 2)
Experimental
干预措施: BMS-866949 (Drug)
BMS-866949 (Panel 2)
Experimental
干预措施: Placebo (Drug)
BMS-866949 (Panel 3)
Experimental
干预措施: BMS-866949 (Drug)
BMS-866949 (Panel 3)
Experimental
干预措施: Placebo (Drug)
BMS-866949 (Panel 4)
Experimental
干预措施: BMS-866949 (Drug)
BMS-866949 (Panel 4)
Experimental
干预措施: Placebo (Drug)
BMS-866949 (Panel 5)
Experimental
干预措施: BMS-866949 (Drug)
BMS-866949 (Panel 5)
Experimental
干预措施: Placebo (Drug)
BMS-866949 (Panel 6)
Experimental
干预措施: BMS-866949 (Drug)
BMS-866949 (Panel 6)
Experimental
干预措施: Placebo (Drug)
BMS-866949 (Panel 7)
Experimental
干预措施: BMS-866949 (Drug)
BMS-866949 (Panel 7)
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Primary endpoint is safety and tolerability evaluated by VS, ECG, clinical lab assessments and AEs
时间窗: up to Day 14 +/- 2 days post-dose
次要结局
- Single dose pharmacokinetics parameters of BMS-866949 [Cmax, Tmax, T-HALF, AUC (0-T), AUC (INF)] will be analyzed using blood samples(Blood samples will be taken up to 144 hour post-dose)
研究者
研究点 (1)
Loading locations...
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