NCT01367535已完成1 期
A Phase I, Randomized, Open-Label, Active- and Placebo-Controlled Parallel Group Study of the Effect of Subcutaneous and Intravenous Methylnaltrexone on CYP450 2D6 Activity in Healthy Extensive Metabolizers of Dextromethorphan
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
- 54
- 试验地点
- 1
- 主要终点
- Plasma Concentration of MNTX
研究概览
简要总结
This study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males between the ages of 18 and 55
- •Non-Smokers
- •Body weight range form 154-220 lbs
- •No history of clinically significant metabolic disorders.
排除标准
- •Any history of low CYP450 2D6 activity
- •History of alcohol abuse or recreational drugs
- •History of any clinically significant disease or condition affecting a major organ system
- •Donation or loss of blood, 60 days proceeding to screening visit.
研究组 & 干预措施
Arm 1
Experimental
干预措施: SC Methylnaltrexone (MNTX) (Drug)
Arm 2
Experimental
干预措施: IV Methylnaltrexone (MNTX) (Drug)
Arm 3
Active Comparator
干预措施: Oral Paroxetine (Drug)
Arm 4
Placebo Comparator
干预措施: SC Placebo (Drug)
结局指标
主要结局
Plasma Concentration of MNTX
时间窗: 4 months
The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity.
次要结局
- Plasma Concentration of Paroxetine(4 months)
研究者
研究点 (1)
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