A Study to Characterize the Time Course of Reversal of Opioid (Fentanyl)-Induced Respiratory Depression Following Administration of Nalmefene Autoinjector 1.5 mg (0.94% MgCl2) Intramuscular and Narcan® 4 mg Intranasal in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Minute Ventilation 5 Minutes From Opioid Induced Nadir
研究概览
简要总结
The purpose of this study is to determine the pharmacodynamics (change in minute ventilation) of nalmefene when given as an autoinjector intramuscularly (IM; into the thigh) compared to naloxone when given intranasally (IN; into the nose) to healthy subjects with prior opioid exposure under steady state fentanyl concentrations (opioid agonism).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nalmefene Hydrochloride (HCl) injection
Nalmefene Hydrochloride injection 1.5 mg for intramuscular (IM) administration
干预措施: Nalmefene HCl injection (Drug)
Narcan intranasal
Naloxone 4 mg for intranasal (IN) administration
干预措施: Naloxone HCl intranasal (Drug)
结局指标
主要结局
Change in Minute Ventilation 5 Minutes From Opioid Induced Nadir
时间窗: 5 minutes after opioid antagonist administration
To assess the change in minute ventilation at 5 minutes of intramuscular nalmefene and intranasal naloxone reversal from the opioid induced nadir.
次要结局
- Change in Minute Ventilation at 2.5, 5, 10, 15, 20, 30, and 90 Minutes From Opioid Induced Nadir(Baseline, 2.5, 5, 10, 15, 20, 30, and 90 minutes after opioid antagonist administration)
- Maximum Plasma Concentration (Cmax)(up to 24 hours post-dose)
- Area Under the Curve (AUCt)(up to 24 hours post-dose)
- Area Under the Curve (AUCinf)(up to 24 hours post-dose)
- Area Under the Curve (AUC0-2.5)(2.5 minutes post-dose)
- Time to Maximum Plasma Concentration (Tmax)(up to 24 hours post-dose)
- Half-life (T1/2)(up to 24 hours post-dose)
- Area Under the Curve (AUC0-5)(5 minutes post-dose)
- Area Under the Curve (AUC0-10)(10 minutes post-dose)
- Area Under the Curve (AUC0-15)(15 minutes post-dose)
- Area Under the Curve (AUC0-20)(20 minutes post-dose)
- Time to First Measurable Plasma Concentration (Tlag)(up to 24 hours post-dose)