NCT00581191终止1 期
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SLV-351 Administered Orally to Healthy Subjects
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 72 人开始时间: 2008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
- 72
- 主要终点
- Safet and tolerability
研究概览
简要总结
Safety and tolerability of single oral doses in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men, aged 18-50 years.
- •Women of nonchildbearing potential, aged 18-50 years.
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
0.5 mg SLV-351 (fasted)
干预措施: SLV-351 (Drug)
2
Experimental
1 mg SLV-351 (fasted)
干预措施: SLV-351 (Drug)
3
Experimental
2.5 mg SLV-351 (fasted)
干预措施: SLV-351 (Drug)
4
Experimental
5 mg SLV-351 (fasted)
干预措施: SLV-351 (Drug)
5
Experimental
10 mg SLV-351 (fasted)
干预措施: SLV-351 (Drug)
6
Experimental
15 mg SLV-351 (fasted)
干预措施: SLV-351 (Drug)
7
Experimental
20 mg SLV-351 (fasted)
干预措施: SLV-351 (Drug)
8
Experimental
30 mg SLV-351 (fasted)
干预措施: SLV-351 (Drug)
9
Experimental
xx mg SLV-351 (fasted and fed)
干预措施: SLV-351 (Drug)
结局指标
主要结局
Safet and tolerability
时间窗: 35 days
次要结局
- PK and PD(35 days)
研究者
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