Two-Period, Two-Treatment, Randomized Crossover Study of the Pharmacokinetics of Nalmefene by Intranasal and Intramuscular Administration in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax)
研究概览
简要总结
This study is to determine the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given intranasally (IN;into the nose) compared to a dose of nalmefene when given intramuscularly (IM; into the muscle); to compare the blood levels of nalmefene when given IN to nalmefene when given IM; and to evaluate the safety and tolerability of nalmefene IN.
详细描述
Open-label, randomized, 2-period, 2-treatment, 2-sequence, crossover study in 68 healthy volunteers. Subjects will be assigned to each of the 2 possible sequences. Each subject will receive 2 treatments during the 2 dosing periods: Intranasal (IN) dose of 3 mg nalmefene hydrochloride and intramuscular (IM) dose of 1.0 mg nalmefene, with a 4 day washout period between doses. Screening can occur up to 28 days before baseline admission, subjects will then stay in the inpatient facility for 7 days to complete the treatment phase of the study and will be discharged following completion of the discharge procedures at the end of the last period. Subjects will be called 3 to 5 days after discharge to inquire concerning Adverse Events (AEs) and concomitant medications since 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 30 kg/m2, inclusive
- •Adequate venous access
- •Subjects must be non-smokers
排除标准
- •History of clinically significant disease
- •Significant trauma injury, major surgery, open biopsy within 30 days prior to screening
- •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
研究组 & 干预措施
Intranasal Nalmefene
Nalmefene hydrochloride nasal spray, 3mg, 1 spray
干预措施: Nalmefene Hydrochloride (Drug)
Intramuscular Nalmefene
Nalmefene injection, 1mg, 1 injection
干预措施: Nalmefene (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax)
时间窗: 48 hours
Maximum concentration of plasma nalmefene comparing IN to IM
Area Under the Curve (AUC-inf)
时间窗: 48 hours
Area under the curve of plasma nalmefene comparing IN to IM
Time to Maximum Plasma Concentration (Tmax)
时间窗: 48 hours
Time to maximum concentration of plasma nalmefene comparing IN to IM
Half-life (t1/2)
时间窗: 48 hours
Half life of plasma nalmefene comparing IN to IM
次要结局
未报告次要终点