NCT02148185已完成1 期
A Phase I, Open-label Study to Evaluate PK, PD, and Safety of a Single Oral Dose of MT-1303 in Subjects With Moderate to Severe Crohn's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Plasma concentration of MT-1303
研究概览
简要总结
The purpose of this study is to evaluate PK, PD and safety of a single oral dose of MT-1303 in subjects with Crohn's disease.
详细描述
This is a Phase I, open-label, non-randomised, multicenter single-dose study to evaluate PK, PD, and safety of a single oral dose of MT-1303 in subjects with moderate to severe active Crohn's disease (ileal and ileo-colonic type).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who were diagnosed as Crohn's disease
- •Subjects who were confirmed as ileal or ileo-colonic type by image inspection.
- •Disease severity determined as either "moderate" or "severe"
排除标准
- •Present or past history of gastrointestinal surgery which may have impact on drug absorption
- •Subjects with stenosis or fistula in small intestine or colon
研究组 & 干预措施
MT-1303
Experimental
干预措施: MT-1303 (Drug)
结局指标
主要结局
Plasma concentration of MT-1303
时间窗: 15 time points up to 29 days
Plasma concentration of MT-1303 metabolite
时间窗: 15 time points up to 29 days
次要结局
- Change from baseline in lymphocyte count after MT-1303 administration(16 time points up to 29 days)
- Type of adverse events(29 days)
研究者
研究点 (1)
Loading locations...
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