临床试验/NCT01367587

NCT01367587已完成2 期

Safety and Gastrointestinal Effects of Multiple-Dosed Intravenous Methylnaltrexone in Healthy Human Volunteers

Bausch Health Americas, Inc.1 个研究点分布在 1 个国家目标入组 12 人开始时间: 2002年4月最近更新: 2019年11月27日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Bausch Health Americas, Inc.
入组人数: 12
试验地点: 1
主要终点: Peak Plasma Concentration of IV MNTX

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study evaluates the safety of multiple doses of IV MNTX in normal healthy adults.

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 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Must be male or non-pregnant female volunteers
•Must be 18 to 65 yrs of age
•Must have no significant active disease states

排除标准

•History or current evidence of disease (cardiovascular, respiratory, endocrine, renal, hepatic, hematological, or psychiatric)
•Illicit drug users
•Subjects who received an experimental new drug in the past 30 days
•Subjects with any laboratory findings outside normal limits

研究组 & 干预措施

Arm 1

Experimental

干预措施: IV Methylnaltrexone (Drug)

结局指标

主要结局

Peak Plasma Concentration of IV MNTX

时间窗: 3 weeks

To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

次要结局

Time to Maximum Plasma Concentration of IV MNTX(3 weeks)
Clearance of IV MNTX(3 weeks)
Half-life of IV MNTX(3 weeks)
Volume of Distribution of IV MNTX(3 weeks)
Area Under the Plasma Concentration versus Time Curve (AUC) of IV MNTX(3 weeks)
Percentage of IV MNTX Excreted in Urine(3 weeks)

研究者

发起方

Bausch Health Americas, Inc.

申办方类型

Industry

研究点 (1)

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