NCT01366365已完成1 期
A Phase 1 Randomized, Double-Blind, Placebo Controlled Parallel Group Study of the Pharmacokinetics, Safety and Tolerability of Methylnaltrexone Bromide Administered as Single and Multiple Intravenous Doses to Healthy Adults and Elderly Male and Female Subjects
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
- 28
- 试验地点
- 1
- 主要终点
- Clearance of MNTX
研究概览
简要总结
This double-blind, randomized, two-cohort, placebo-controlled, parallel group study characterized the pharmacokinetics, safety, and tolerability of MNTX following single doses and at steady-state during multiple dosing and assessed the effects of aging on the pharmacokinetics, safety and tolerability of MNTX.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Males and females who were between the ages of 18 and 45 years and healthy males and females who were 65 years of age and older.
- •Subjects who were non-smokers
- •Subjects with body weights within range of 70-100 kg (154-220 lbs).
排除标准
- •Subjects who had previously been exposed to MNTX
- •Subjects with a history of vasovagal episodes or fainting within the past five years
- •Subjects with a history of psychiatric or neurologic disorder
- •Subjects with a history of narrow-angle glaucoma or intraocular hypertension
- •Subjects who had tested positive for hepatitis B surface antigen, IgM hepatitis B core antibody, hepatitis C antibody, or HIV
- •Subjects who have had a diagnosis of alcohol or substance dependence.
研究组 & 干预措施
Arm 1
Experimental
IV methylnaltrexone (MNTX)
干预措施: methylnaltrexone (Drug)
Arm 2
Placebo Comparator
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Clearance of MNTX
时间窗: 7 days
Evaluate the PK of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses
次要结局
- Half-life of MNTX(7 days)
- Volume of distribution of MNTX(7 days)
- Area under the plasma concentration (AUC) of MNTX(7 days)
- Number of Subjects with Adverse Events(7 days)
研究者
研究点 (1)
Loading locations...
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