Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters of nalmefene
研究概览
简要总结
This study will be to compare the pharmacokinetics of nalmefene administration intranasal with and without an absorption enhancer compared to an intramuscular injection.
详细描述
This study will be an inpatient, double-blind, randomized, crossover study involving 14 healthy volunteers. Each subject will receive 4 treatments during the 4 dosing periods.Subjects will stay in the inpatient facility for 17 days to complete the entire study and be discharged following completion of discharge procedures at the end of the last period. Subjects will be called 3 to 5 days after discharge to inquire concerning adverse events and concomitant medications since discharge. After obtaining informed consent, subject will be screened for eligibility. ON the day after clinic admission, subjects will be administered the intranasal-formulated drug in randomized order with 4 days between doses; the intramuscular dose will be administered during the fourth (last) treatment period.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Males and females 18 to 55 years of age
- •Provide written informed consent
- •Body Mass index (BMI) ranging from 18 to 32 kg/m2
- •Adequate venous access
- •No clinically significant concurrent medical conditions
- •Males subjects must agree to use an acceptable method of birth of contraception with female partners as well as not to donate sperm throughout the study and for 90 days after the last study drug administration
- •Female subjects of child bearing potential must agree to use an acceptable method of birth control from the start of screening until 30 days after completing the study. Oral contraceptives are prohibited
- •Agree not to ingest alcohol, drinks containing xanthine >500 mg / day (e.g., Coca Cola, tea, coffee, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study
排除标准
- •Please contact the site for more information
研究组 & 干预措施
Nalmefene (high dose)
Nalmefene (high dose) intranasal one time during the 17 day inpatient treatment period
干预措施: Nalmefene (Drug)
Nalmefene and Intravail
Nalmefene (high dose) with Intravail intranasal one time during the 17 day inpatient treatment period
干预措施: Nalmefene (Drug)
Nalmefene (low dose)
Nalmefene (low dose) intranasal one time during the 17 day inpatient treatment period
干预措施: Nalmefene (Drug)
Nalmefene Intramuscular
Nalmefene intramuscular one time during the 17 day inpatient treatment period
干预措施: Nalmefene (Drug)
结局指标
主要结局
Pharmacokinetic parameters of nalmefene
时间窗: 17 days
Maximum plasma concentration, time of Maximum observed concentration and area under the concentration-time curve
次要结局
- Safety and tolerability(17 days)