NCT01367483已完成1 期
An Open-Label, Phase I, Single Dose Study of the Pharmacokinetics, Mass Balance and Disposition of Intravenously Administered 14C-Methylnaltrexone in Normal, Healthy Volunteers
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
- 6
- 试验地点
- 1
- 主要终点
- Peak Plasma and Whole Blood Concentration (Cmax) of IV MNTX
研究概览
简要总结
This is an open-label, radiotracer study, to be conducted in healthy, normal, male volunteers. It will entail intravenous administration of a single dose of 14C-MNTX, collection of excretions, and periodic drawing of blood samples. Exhaled 14CO2 will also be sampled as a measure of the extent of possible metabolic MNTX demethylation.
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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males between 18-45
- •Subject weight between 70 and 90 kg
- •In good physical health, with no evidence at screening of acute or chronic disease likely to affect the investigation
排除标准
- •History or evidence of cardiovascular, gastrointestinal, hepatic, neurological, pulmonary, renal, or other significant chronic condition.
- •Consumption of barbiturates or other inducers or inhibitors of CYP450 isoforms
- •History of or predisposition to erratic or abnormal bowel function.
研究组 & 干预措施
Arm1
Experimental
MNTX active treatment
干预措施: IV methylnaltrexone (MNTX) (Drug)
结局指标
主要结局
Peak Plasma and Whole Blood Concentration (Cmax) of IV MNTX
时间窗: 5.5 days
To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.
次要结局
- Urinary Clearance of IV MNTX(5.5 days)
- Time to Maximum (Tmax) in Plasma and Whole Blood Concentration of IV MNTX(5.5 Days)
- Clearance of IV MNTX(5.5 days)
- Half-life of IV MNTX(5.5 days)
- Volume of Distribution of IV MNTX(5.5 days)
研究者
研究点 (1)
Loading locations...
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