NCT01366378已完成1 期
A Phase 1, Open-Label, Study of the Effect of Cimetidine, a Known Inhibitor of Active Renal Secretion, on the Single-Dose Pharmacokinetics of Intravenously-Administered Methylnaltrexone in Healthy Adults
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
- 18
- 试验地点
- 1
- 主要终点
- Peak plasma concentration (Cmax) of MNTX prior to and following multi-dose cimetidine regimen
研究概览
简要总结
This open-label study assesses the single-dose pharmacokinetics of intravenously-administered MNTX in healthy adult male and female subjects in the absence of, and in the presence of, orally-administered cimetidine.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females between the ages of 18 and 45
- •Subjects who are non-smokers
- •Subjects with body weights with range of 154-220 lbs.
排除标准
- •Females who are pregnant or lactating
- •Subjects with a history of any clinically significant disease or condition affecting a major organ system
- •Subjects with ECG abnormalities
- •Subjects who have tested positive for hepatitis B, hepatitis C or HIV
- •Subjects who have had a diagnosis of alcohol or substance dependence with the past 12 months
- •Subjects with positive urine results for drugs of abuse.
研究组 & 干预措施
Arm 1
Experimental
methylnaltrexone (MNTX)
干预措施: methylnaltrexone (Drug)
结局指标
主要结局
Peak plasma concentration (Cmax) of MNTX prior to and following multi-dose cimetidine regimen
时间窗: 7 days
To assess the potential effects of cimetidine on the pharmacokinetics of MNTX
次要结局
- Area under the plasma concentration (AUC) of MNTX prior to and following a multi-dose cimetidine regimen(7 days)
- Clearance (both total and renal)of MNTX prior to and following a multi-dose cimetidine regimen(7 days)
- Number of subject with adverse events as measured before, during, and after administration of cimetidine(7 days)
- Half-life of MNTX prior to and following a multi-dose cimetidine regimen(7 days)
- Volume of distribution of MNTX prior to and following a multi-dose cimetidine regimen(7 days)
研究者
研究点 (1)
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