JPRN-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.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
研究概览
简要总结
DSP-6952 was well tolerated when administered as a single dose of 4 to 120 mg or multiple doses of 4 to 120 mg/day administered for 7 days with a dose-proportional pharmacokinetic profile. The PD assessments results suggested that DSP-6952 has effects on bowel movement.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 64age old（—）
- 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.
研究者
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