NCT02218021已完成1 期
A Randomized, Double-Blind, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Abuse Potential and Safety of Orally Administered Samidorphan in Non-Dependent Recreational Opioid Users
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
- 59
- 试验地点
- 1
- 主要终点
- Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)
研究概览
简要总结
The purpose of this study is to evaluate the abuse potential and safety of samidorphan in healthy, non-dependent, adult, recreational opioid users.
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
- Double (Participant, 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
- •Be in good general physical health
- •Body mass index of 18-34 kg/m2, inclusive with minimum weight of 50 kg
- •Recreational opioid use experience for non-therapeutic purposes (at >/= 10 times in lifetime and >/= 1 in previous 3 months
- •Agree to use an approved method of birth control for the duration of the study
- •Additional criteria may apply
排除标准
- •Currently pregnant or breastfeeding
- •History of or current infection with hepatitis B virus, hepatitis C virus or HIV
- •Current or history of any clinically significant medical or psychiatric condition
- •Current or history of in the last 2 years of dependence on alcohol or any illicit drugs
- •Have used any prescription or over-the-counter medication, including natural health products (with the exception of prescription birth control or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days
- •Have a history of intolerance or hypersensitivity to opioid antagonists, opioid agonists or related drugs (eg, naltrexone, naloxone, oxycodone, morphine)
- •Additional criteria may apply
研究组 & 干预措施
Samidorphan Dose 2
Experimental
干预措施: Samidorphan (Drug)
Samidorphan Dose 3
Experimental
干预措施: Samidorphan (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Oxycodone Dose 1
Active Comparator
干预措施: Oxycodone (Drug)
Oxycodone Dose 2
Active Comparator
干预措施: Oxycodone (Drug)
Samidorphan Dose 1
Experimental
干预措施: Samidorphan (Drug)
结局指标
主要结局
Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)
时间窗: Approximately 4 weeks
次要结局
- Safety: Incidence of adverse events (AEs)(Approximately 5.5 weeks)
- Pharmacokinetics: Plasma concentrations of samidorphan and metabolite(Approximately 4 weeks)
研究者
研究点 (1)
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