NCT02068105已完成1 期
A Phase 1, Randomized, Two-part Study to Evaluate the Relative Bioavailability of Two Formulations of ALKS 5461 and the Effect of Dose Titration of ALKS 5461 in Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Relative bioavailability of ALKS 5461 treatment groups
研究概览
简要总结
This is a study to test the safety of ALKS 5461 in healthy adults.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Be in good physical health
- •Body mass index of 18-30 kg/m2
- •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 Human Immunodeficiency Virus (HIV)
- •Current or history of any clinically significant medical or psychiatric condition
- •Current abuse or dependence on alcohol or any illicit drugs
- •Have used nicotine within 90 days
- •Have used St. John's Wort or consumed grapefruit, grapefruit juice, or juices containing grapefruit within 30 days
- •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 used opioids 30 days prior to screening or have an anticipated need for opioid medication at any point during the study
- •Have a history of intolerance or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
- •Additional criteria may apply
研究组 & 干预措施
ALKS 5461 Dose 3
Experimental
干预措施: ALKS 5461 (Drug)
ALKS 5461-A
Experimental
干预措施: ALKS 5461 (Drug)
ALKS 5461-B
Experimental
干预措施: ALKS 5461 (Drug)
ALKS 5461 Dose 1
Experimental
干预措施: ALKS 5461 (Drug)
ALKS 5461 Dose 2
Experimental
干预措施: ALKS 5461 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Relative bioavailability of ALKS 5461 treatment groups
时间窗: 21 days
The parameters for determining the bioavailability include Cmax, AUC last, and AUC(0-infinity).
次要结局
- Safety and tolerability: Incidence of adverse events(21 days)
研究者
研究点 (1)
Loading locations...
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