NCT00401479已完成1 期
An Exploratory Phase I Study in Healthy Volunteers of GI Transit Following Administration of the ß3-Adrenergic Receptor Agonist, Solabegron (Study B3I106248)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- colonic emptying rate by radiolabeled scintigraphy
研究概览
简要总结
This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, retards the emptying of the colon and increases total colonic transit time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double
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
- •Subjects with no evidence of current or past history suggestive of gastrointestinal disease or disorder or medical illness that could compromise interpretation of the study.
- •no clinically significant laboratory results collected at the screening visit
- •men: body weight greater than or equal to 50kg (110 lbs)
- •women: body weight greater than or equal to 45kg (100 lbs)
- •BMI between 18.5 - 35 kg/m2
排除标准
- •Females who are nursing or pregnant.
- •history of inflammatory bowel disease
- •history of gastric ulcers within 12 months of signing the informed consent form
- •tobacco users
结局指标
主要结局
colonic emptying rate by radiolabeled scintigraphy
时间窗: throughout the study
次要结局
- Safety and tolerability: ECG, vital signs, adverse events, clinical lab tests. Diary card collection of stool frequency Stool consistency and ease of passage Blood levels of GW427353(throughout the study)
研究者
研究点 (2)
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