NCT00985478终止1 期
A Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV342 in Young Healthy Male Subjects
Abbott Products1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2010年1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
- 终止
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Safety and tolerability parameters: adverse event, vital signs, 12-Lead ECG, continuous lead II ECG monitoring, laboratory safety variables and physical examination
研究概览
简要总结
First in man study with single and multiple rising doses with SLV342
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A
Experimental
SLV342 suspension or capsule
干预措施: SLV342 (Drug)
B
Placebo Comparator
matching placebo
干预措施: placebo (Drug)
结局指标
主要结局
Safety and tolerability parameters: adverse event, vital signs, 12-Lead ECG, continuous lead II ECG monitoring, laboratory safety variables and physical examination
时间窗: 28 Days
次要结局
- Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR(28 days)
- Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring(28 days)
- Midazolam PK parameters(24 hours)
研究者
研究点 (1)
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