jRCT2080223728已完成1 期
A single-dose ascending study and a multiple-dose study in healthy male subjects and a multiple-dose study in subjects who have no more than 3 spontaneous bowel movements per week to investigate the tolerability, safety, pharmacokinetics, and pharmacodynamics of DSP-6952, and a single-dose study in healthy male subjects to examine the effect of food.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Vital signs
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- (single-dose Administration, Multiple-dose Administration) double-blind, Randomized, Placebo-controlled (food-effect Study Part) double-blind, Randomized, Placebo-controlled
- 主要目的
- Other
入排标准
- 年龄范围
- 20age old over 至 64age old under（—）
- 性别
- All
入选标准
- •Part A and B
- •Healthy adult male subjects
- •Subjects who were aged 20 through 39 years at informed consent etc.
- •Adult male or female subjects with spontaneous bowel movements 3 times or less a week
- •Subjects who were aged 20 through 64 years at informed consent etc.
排除标准
- •Subjects with any history of diseases that might be unsuitable for participation in the clinical study etc.
结局指标
主要结局
Vital signs
Pulse rate, blood pressure and body temperature
次要结局
- Cmax and AUC of DSP-6952
- Frequency of bowel movements
研究者
研究点 (1)
Loading locations...
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