NCT01271998已完成1 期
Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg TR-701 Free Acid in Healthy Volunteers
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年12月8日最近更新:
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
- 20
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters from plasma.
研究概览
简要总结
The primary purpose of this study is to determine the steady-state plasma pharmacokinetics (PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar macrophages (AM) of healthy volunteers.
详细描述
No applicable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females, between 18 and 55 years of age, inclusive
- •Females must be nonpregnant, nonlactating, and either postmenopausal or surgically sterile or practicing an effective method of birth control
- •Males must be surgically sterile, abstinent, or practicing an effective method of birth control
- •BMI between 20 and 34.9 kg/m2, inclusive
排除标准
- •Allergy to lidocaine, midazolam, or other anesthetics/sedatives of similar classes
- •Physician-diagnosed migraine headaches within 3 years
- •Previous enrollment in a TR-701 or TR-701 FA trial
研究组 & 干预措施
healthy volunteer
Experimental
healthy volunteers
干预措施: TR-701 FA (Drug)
结局指标
主要结局
Pharmacokinetic parameters from plasma.
时间窗: Day 3
Pharmacokinetic parameters compared with baseline measurements.
次要结局
未报告次要终点
研究者
研究点 (1)
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