NCT02272764已完成1 期
A Phase 1 Study of the Effects of Itraconazole on the Pharmacokinetics of ALKS 5461 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
- 24
- 试验地点
- 1
- 主要终点
- Drug-Drug Interaction - AUC0-t
研究概览
简要总结
This study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.
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
- •Has a body mass index (BMI) of 18.0 - 30.0 kg/m2
- •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
- •Has current evidence, or history of any clinically significant medical or psychiatric condition or observed abnormality
- •Is currently pregnant or breastfeeding
- •Has a history of or current infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV)
- •Has a lifetime history of opioid abuse or dependence
- •Has current abuse or dependence on alcohol or any drugs
- •Has used nicotine within 90 days prior to randomization
- •Additional criteria may apply
研究组 & 干预措施
Itraconazole
Other
Itraconazole or placebo
干预措施: Itraconazole (Drug)
ALKS 5461
Experimental
ALKS 5461 or placebo Sublingual tablet
干预措施: ALKS 5461 (Drug)
结局指标
主要结局
Drug-Drug Interaction - AUC0-t
时间窗: Up to 48 hours
Area under the concentration time curve from time zero to the last measureable time point (AUC0-t) of ALKS 5461 in the presence and absence of itraconazole
Drug-Drug Interaction - AUC0-inf
时间窗: Up to 48 hours
Area under the concentration time curve from time zero to infinity (AUC0-inf) of ALKS 5461 in the presence and absence of itraconazole
Drug-Drug Interaction - Cmax
时间窗: Up to 48 hours
Maximum plasma concentration (Cmax) of ALKS 5461 in the presence and absence of itraconazole
次要结局
- Safety and tolerability will be measured by incidence of adverse events(Up to 32 Days)
研究者
研究点 (1)
Loading locations...
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