NCT04849559已完成1 期
VP-VLY-686-1301: A Single Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Tradipitant on Satiation, Gastric Volume, Gastric Accommodation and Gastric Emptying in Healthy Volunteers
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
- 27
- 试验地点
- 1
- 主要终点
- Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)
研究概览
简要总结
To evaluate the effects of tradipitant relative to placebo on satiation, gastric volume, gastric accommodation, and gastric emptying in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Able to provide written consent
- •Body Mass Index (BMI) of 18-35 kg/m2
- •No medical problems or chronic diseases
排除标准
- •Diagnosis of gastrointestinal diseases
- •Structural or metabolic diseases that affect the GI system
- •A positive test for drugs of abuse at screening
研究组 & 干预措施
Tradipitant
Experimental
Oral Capsule
干预措施: Tradipitant (Drug)
Placebo
Placebo Comparator
Oral Capsule
干预措施: Placebo (Drug)
结局指标
主要结局
Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)
时间窗: 9 Days
Fasting Gastric volume
Accommodation Volume as Measured by SPECT
时间窗: 9 Days
Gastric Accommodation post 300mL Ensure
Satiation Expressed as Volume to Fullness as Measured by Satiation Test
时间窗: 9 Days
Gastric Emptying Half-time of Solids as Measured by Scintigraphy
时间窗: 9 Days
Gastric Emptying Solids, T50%, Min
次要结局
未报告次要终点
研究者
研究点 (1)
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