NCT02479308已完成1 期
The Effect of ALKS 5461 on QT Intervals in Healthy Volunteers
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
- 129
- 试验地点
- 1
- 主要终点
- Change in QT interval corrected for heart rate using the Fridericia formula (QTcF)
研究概览
简要总结
This study will evaluate the effects of ALKS 5461 on QT intervals in healthy volunteers as well as evaluate the safety and tolerability of ALKS 5461.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Have a body mass index (BMI) of 18.0-30.0 kg/m2 at screening
- •Is physically healthy
- •Agree to abide by the contraception requirements for the duration of the study
- •Additional criteria may apply
排除标准
- •Have a positive pregnancy test and/or be currently breastfeeding
- •Have a history of or current infection with Hepatitis B virus, Hepatitis C virus, or human immunodeficiency virus (HIV)
- •Have current evidence of or history of any clinically significant medical or psychiatric condition or observed abnormality
- •Have any skin condition likely to interfere with ECG electrode placement or adhesion
- •Have current abuse or dependence (within the past 5 years) on any drugs (exclusive of nicotine or caffeine)
- •Have used any prescription or over-the-counter (OTC) medication, including natural health products or dietary supplements (with the exception of prescription contraceptives or hormonal replacements, acetaminophen, ibuprofen, or multivitamins), or have consumed grapefruit or any grapefruit products within 14 days prior to the first study drug dose
- •Have consumed alcohol-, caffeine-, or xanthine-containing products within 24 hours prior to the first study drug dose
- •Have used nicotine within 90 days prior to the first study drug dose
- •Have used opioids 30 days prior to screening, or have an anticipated need for opioid medication during the study
- •Additional criteria may apply
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
ALKS 5461
Experimental
Sublingual tablet
干预措施: ALKS 5461 (Drug)
Moxifloxacin
Active Comparator
Oral tablet
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Change in QT interval corrected for heart rate using the Fridericia formula (QTcF)
时间窗: Up to 14 days
次要结局
- Change in heart rate(Up to 14 days)
- Incidence of abnormal ECG(Up to 13 days)
- Tabulation of ECG morphology(Up to 14 days)
- Correlation of plasma drug levels with QT interval(Up to 14 days)
- Maximum observed plasma concentration (Cmax) for ALKS 5461(Up to 14 days)
- Incidence of adverse events (AEs)(Up to 14 weeks)
- Change in PR interval(Up to 14 days)
- Change in QRS interval(Up to 14 days)
- Time to reach the maximum plasma concentration (Tmax) for ALKS 5461(Up to 14 days)
- AUC(0-last): Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for ALKS 5461(Up to 14 days)
- AUC(0-inf): Area under the plasma concentration-time curve from time 0 to infinity for ALKS 5461(Up to 14 days)
- Terminal elimination half-life (T1/2) for ALKS 5461(Up to 14 days)
研究者
研究点 (1)
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