NCT01539473已完成1 期
A Phase 1, Blinded, Placebo-Controlled, Crossover TR-701 FA Study of Blood Pressure Response Post-Tyramine Challenge
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 30 人开始时间: 2012年2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
- 30
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
Phase 1 study to determine the effect of oral TR-701 FA on SBP response when administered with tyramine
详细描述
This is a Phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to determine the effect of 200 mg oral TR-701 FA on SBP response when administered with tyramine in healthy adult male and female volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects between 18 to 45 years of age, inclusive
- •Body mass index between 19 kg/m2 and 31 kg/m2, inclusive
- •Healthy subjects with no clinically significant abnormalities identified by a detailed medical history,
排除标准
- •Systolic blood pressure >130 mmHg or <90 mmHg measured after 10 minutes in the supine position at Screening or at admission to the study center
- •Heart rate >90 bpm or <45 bpm measured after 10 minutes in the supine position
- •Electrocardiogram (ECG) finding of QTc interval >500 msec, or other clinically significant ECG abnormality at the Screening Visit
研究组 & 干预措施
TR-701 FA with Tyramine
Experimental
TR-701 FA 200 oral with Tyramine
干预措施: TR-701 FA with Tyramine (Drug)
Placebo-controlled with Tyramine
Placebo Comparator
Placebo-controlled with Tyramine
干预措施: Placebo-controlled withTyramine (Drug)
结局指标
主要结局
Systolic Blood Pressure
时间窗: 14 days
To assess tyramine dose required to cause increase of 30 mmHg in systolic blood pressure
次要结局
未报告次要终点
研究者
研究点 (1)
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