A Two-part Open Label Study of the Pharmacodynamic Effects of Intranasal Nalmefene Compared to Intranasal Naloxone in Healthy Volunteers Under Steady State Opioid Agonism
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in Minute Ventilation
研究概览
简要总结
This study is to determine the pharmacodynamics (the effects of the drug and mechanisms of their action within the body) of Nalmefene when given intranasally (IN; into the nose) compared to intranasal naloxone when given to healthy volunteers under steady state opioid agonism.
详细描述
Open-label, 2-part study. Part 1 is a pilot study to determine the relationship between opioid agonism and suppression of carbon dioxide induced increases in minute ventilation prior to opioid exposure. Part 2 will be a randomized, 2 period, 2 treatment, crossover study to evaluate the pharmacodynamic effects of intranasal (IN) nalmefene compared to IN naloxone to reverse opioid-induced suppression of carbon dioxide induced increases in minute ventilation, in healthy volunteers with prior opioid exposure.
Both Part 1 and Part 2 of the study will consist of an outpatient Screening Visit taking place 28 days prior to admission, an in-clinic Treatment Phase consisting of a 6 or 7 day inpatient stay, and a Follow-Up Phone Call conducted 3 to 7 days after discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Male or female aged 18 to 55 years inclusive
- •BMI ranging from 18 to 32 kg/m2, inclusive
- •Adequate venous access
- •Healthy subjects and non-dependent who are non dependent opioid experienced users, opioid experience defined as exposure to an opioid on at least 1 occasion prior to screening
排除标准
- •History of clinically significant disease
- •Significant trauma injury, major surgery, open biopsy within 30 days prior to screening
- •Subject who has a difficult airway for intubation.
- •Following an abnormal diet 4 weeks prior to screening
- •Use of over-the-counter medications, dietary supplements, herbal products, vitamins or opioid analgesics 14 days before intervention
- •Use of enzyme altering drugs 30 days before intervention
- •Use of nasal products 28 days before intervention and throughout the study
- •Previous or current opioid, alcohol, or other drug dependence
- •Donated or received blood 30 days before intervention
- •Women who are pregnant or breastfeeding at screening
- •Women of childbearing potential unless surgically sterile or use effective contraception
- •Current or recent upper respiratory tract infection
- •Allergic to nalmefene or naloxone or known hypersensitivity reaction to plastics.
研究组 & 干预措施
Intranasal Nalmefene
Nalmefene hydrochloride nasal spray, 3mg, 1 spray
干预措施: Nalmefene hydrochloride (Drug)
Intranasal Naloxone
Naloxone hydrochloride nasal spray, 4mg, 1 spray
干预措施: Naloxone hydrochloride (Drug)
结局指标
主要结局
Change in Minute Ventilation
时间窗: 5 minutes
Change in minute ventilation from opioid induced nadir
次要结局
- Maximum Change in Minute Ventilation(Up to 2 hours)
- Time to Maximum Change in Minute Ventilation(Up to 2 hours)
- Change in Minute Ventilation(2.5 minutes)