NCT00499629已完成1 期
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of FXR-450 Administered Orally to Healthy Subjects
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2007年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Safety, tolerability
研究概览
简要总结
The primary purpose of the study is to evaluate the safety of FXR-450 in healthy subjects. This study will also evaluate pharmacokinetics (PK) of FXR-450 in healthy subjects.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive at screening.
- •Healthy as determined by the investigator on the basis of screening evaluations.
- •Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
排除标准
- •Any significant medical disease.
- •History of cholecystectomy (removal of gallbladder).
- •Any clinically important finding in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results.
研究组 & 干预措施
1
Active Comparator
Arm 1: FXR 450
干预措施: FXR 450 (Drug)
2
Placebo Comparator
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Safety, tolerability
时间窗: 4 days
次要结局
- pharmacokinetics(4 days)
研究者
研究点 (1)
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