NCT02649062已完成1 期
Study of the Pharmacodynamics of NGM282 on Colonic Transit, Bile Acid Homeostasis, and Fecal Fat in Subjects With Functional Constipation and Healthy Individuals
NGM Biopharmaceuticals, Inc2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2015年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Effect on Colon Transit, as measured by the movement of food through the colon
研究概览
简要总结
The purpose of this study is to determine the effect of NGM282 on colonic transit, bile acid homeostasis, and fecal fat in subjects with functional constipation and healthy individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Functional constipation confirmed by modified Rome III criteria or Healthy Volunteer
排除标准
- •Structural or metabolic diseases/conditions that affect the GI system
- •Diagnosis of dyspepsia, IBS, or significant gastrointestinal symptoms
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
NGM282 Dose 1
Experimental
NGM282
干预措施: NGM282 (Biological)
NGM282 Dose 2
Experimental
NGM282
干预措施: NGM282 (Biological)
结局指标
主要结局
Effect on Colon Transit, as measured by the movement of food through the colon
时间窗: 9 days
次要结局
- Clinical Laboratory Assessments(14 days)
研究者
研究点 (2)
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