NCT00528242已完成2 期
A Randomized, Double Blind, Placebo-controlled, Cross-over Pilot Study to Examine the Safety, Tolerability and Pharmacodynamic Profile of Repeat Oral Doses of SLx-2101 Once Daily for up to 14 Days in Subjects With Secondary Raynaud's Disease.
Response Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2007年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Raynaud's condition scores after 14 days of SLx-2101
研究概览
简要总结
To investigate the severity of secondary Raynaud's disease-related attacks during the 14 days 2101 dosing period.
详细描述
- Number and cumulative duration of Raynaud's attacks.
- Adverse events and changes in vital signs.
- SLx-2101 pharmacokinetic parameters derived after dosing on Day 1 and Day maximum plasma concentration (Cmax), area under the plasma concentration-time curve (AUC0-4), time to Cmax (tmax), and accumulation ratio
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female ages 18 and 65 y.o.
- •BMI Body weight within a body mass index range of 17 - 30 kg/m2 (inclusive).
排除标准
- •Hypersensitivity to the active substance of SLx-2101or to any of the excipients.
- •Past or present disease that is judged by the Investigator to have the potential to interfere with the study procedures, compromise safety, or affect the pharmacokinetic and pharmacodynamic evaluations
研究组 & 干预措施
1
Experimental
SLx-2101
干预措施: SLx-2101 (Drug)
2
Placebo Comparator
Matching Placebo Dose
干预措施: Placebo (Drug)
结局指标
主要结局
Raynaud's condition scores after 14 days of SLx-2101
时间窗: 14 days
次要结局
- Safety and tolerability(14 days)
研究者
研究点 (1)
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