NCT01320332已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo Controlled Study to Assess the Pharmacokinetics, Safety, and Tolerability of ASP3291 Following a Single Oral Dose in Subjects With Ulcerative Colitis
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
- 16
- 试验地点
- 3
- 主要终点
- Pharmacokinetic assessment through analysis of blood, fecal and urine samples
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetics (PK) and to assess safety and tolerability of a single dose of ASP3291 in subjects with ulcerative colitis.
详细描述
After an 11-day screening period, subjects check into a clinic, are dosed on Day 1 and stay in the clinic for 4 days to monitor pharmacokinetic and safety parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Subject has a previously documented diagnosis of ulcerative colitis (UC) with endoscopy and histology consistent with diagnosis
- •If female, the subject is at least 2 years postmenopausal or is surgically sterile per documentation provided by a third party medical professional or the subject agrees to use 2 highly effective methods of birth control during the study and is not pregnant or lactating
- •Subject is willing and able to comply with the study requirements
- •Subject has a body mass index (BMI) of <32 kg/m2
- •Subject has ulcerative colitis requiring treatment with 5-aminosalicylic acid (5-ASA)
排除标准
- •Subject has undergone previous resective colonic surgery
- •Subject has previously diagnosed Crohn's Disease based on medical history
- •Subject has an extension of disease limited to ulcerative proctitis
- •Subject has active peptic ulcer disease based on medical history
- •Subject is currently being treated with any prescription medication except the following: A stable dose of 5-aminosalicylic acid (5-ASA) for at least 2 weeks, oral contraceptives or hormone replacement therapy (HRT)
- •Subject has a history of human immunodeficiency virus (HIV)
- •Subject has a history of severe allergic or anaphylactic reactions
- •Subject has a history of drug or alcohol abuse
研究组 & 干预措施
ASP3291 low dose
Experimental
干预措施: ASP3291 (Drug)
ASP3291 high dose
Experimental
干预措施: ASP3291 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetic assessment through analysis of blood, fecal and urine samples
时间窗: Up to Day 4
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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