NCT02521857已完成1 期
A Phase 1 Study to Evaluate the Impact of Water Consumption on the Pharmacokinetics of Sublingually Administered ALKS 5461
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
- 30
- 试验地点
- 1
- 主要终点
- AUClast
研究概览
简要总结
This study will evaluate the impact of water consumption on the pharmacokinetics of ALKS 5461.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has a body mass index (BMI) of 18.0 - 30.0 kg/m^2
- •Is in good physical health
- •Agrees to use an approved method of contraception for the duration of the study
- •Additional criteria may apply
排除标准
- •Is currently pregnant or breastfeeding
- •Has a history of substance abuse disorder
- •Has used nicotine within 90 days prior to the study or anticipates a need to use nicotine during the study period
- •Has used any prescription or over-the-counter medication, including natural health products or dietary supplements (with the exception of prescription contraceptives or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days prior to study start
- •Has used opioids within 30 days prior to screening, or has an anticipated need for opioid medication at any point during the study
- •Has used alcohol within 72 hours prior to any inpatient period
- •Is a heavy caffeine drinker (regularly consuming 5 or more caffeinated beverages per day)
- •Has a history of intolerance or hypersensitivity to opioids (buprenorphine) or opioid antagonists (naltrexone, naloxone)
- •Additional criteria may apply
研究组 & 干预措施
ALKS 5461
Experimental
Sublingual tablet
干预措施: ALKS 5461 (Drug)
结局指标
主要结局
AUClast
时间窗: Up to 72 hours
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for ALKS 5461
AUCinf
时间窗: Up to 72 hours
Area under the plasma concentration-time curve from time 0 to infinity for ALKS 5461
Cmax
时间窗: Up to 72 hours
Maximum observed plasma concentration for ALKS 5461
次要结局
- Safety and tolerability will be measured by the incidence of Adverse Effects(Up to 46 days)
研究者
研究点 (1)
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