A Phase 1, Single-center, Randomized, Double-blind, Double-dummy, Drug Interaction Study Between AVP-923 and Itraconazole, and Between AVP-786 and Itraconazole in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in plasma concentration of AVP-786 after dosing in combination with itraconazole
研究概览
简要总结
The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor, itraconazole, on the steady-state PK of AVP-923 and AVP-786.
详细描述
A Phase 1, single-center, randomized, double-blind, double-dummy drug interaction study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Healthy adult males and females, 18 to 55 years of age
- •Body Mass Index (BMI) ≥19 and ≤30 kg/m2 (for both males and females)
排除标准
- •History or presence of significant disease
- •History of substance abuse or dependence (except caffeine), or treatment for substance use disorder(s) within the year prior to screening or within 6 months for nicotine including e-cigarettes
- •Use of any tobacco-containing or nicotine-containing products within 6 months prior to the first dose
- •Use of any prescription or the over-the-counter medications within 14 days
研究组 & 干预措施
Sequence 1 - Period 1
AVP-923 and placebo matching AVP-786- BID Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
干预措施: Itraconazole (Drug)
Sequence 1 - Period 2 (after 3-week washout)
AVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
干预措施: Itraconazole (Drug)
Sequence 2 - Period 1
AVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
干预措施: Itraconazole (Drug)
Sequence 2 - Period 2 (after 3-week washout)
AVP-923 and placebo matching AVP-786- BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
干预措施: Itraconazole (Drug)
Sequence 2 - Period 1
AVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
干预措施: AVP-786 (Drug)
Sequence 1 - Period 1
AVP-923 and placebo matching AVP-786- BID Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
干预措施: AVP-923 (Drug)
Sequence 2 - Period 2 (after 3-week washout)
AVP-923 and placebo matching AVP-786- BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
干预措施: AVP-923 (Drug)
Sequence 1 - Period 2 (after 3-week washout)
AVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
干预措施: AVP-786 (Drug)
结局指标
主要结局
Change in plasma concentration of AVP-786 after dosing in combination with itraconazole
时间窗: 16 Days
Change in plasma concentration of AVP-923 after dosing in combination with itraconazole
时间窗: 16 Days
次要结局
- Incidence of adverse events (AEs) for AVP-786 and itraconazole(16 Days)
- Incidence of adverse events (AEs) for AVP-923 and itraconazole(16 Days)