A Phase 1, Single-center, Randomized, Double-blind, Study to Assess the Pharmacokinetics, Safety and Tolerability of Single and Multiple Doses of AVP-786 (Deuterated Dextromethorphan) in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Plasma concentrations of parent and metabolites
研究概览
简要总结
To assess the single- and multiple-dose pharmacokinetic (PK), safety and tolerability of AVP-786 in healthy volunteers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males
- •18 - 45 years of age
- •BMI 18 - 30 kg/m2
排除标准
- •History or presence of significant disease
- •History of substance and/or alcohol abuse within the past 3 years
- •Use of tobacco-containing or nicotine-contining products within 6 months
- •Use of any prescription of over-the-counter (OTC) medication within 14 days
研究组 & 干预措施
Cohorts A and C
Single dose (D1) followed by twice daily dosing for 7 days
干预措施: AVP-786 Dose 1 (Drug)
Cohorts A and C
Single dose (D1) followed by twice daily dosing for 7 days
干预措施: AVP-923 (Drug)
Cohorts B and D
Single dose (D1) followed by twice daily dosing for 7 days
干预措施: AVP-786 Dose 2 (Drug)
Cohorts B and D
Single dose (D1) followed by twice daily dosing for 7 days
干预措施: AVP-923 (Drug)
Cohorts E and F
Single dose (D1) followed by twice daily dosing for 7 days
干预措施: AVP-786 Dose 1/Q Dose 1 (Drug)
Cohorts E and F
Single dose (D1) followed by twice daily dosing for 7 days
干预措施: AVP-923 (Drug)
Cohorts G and I
Single dose (D1) followed by twice daily dosing for 7 days
干预措施: AVP-786 Dose 1/Q Dose 2 (Drug)
Cohorts G and I
Single dose (D1) followed by twice daily dosing for 7 days
干预措施: AVP-923 (Drug)
Cohorts H and J
Single dose (D1) followed by twice daily dosing for 7 days
干预措施: AVP-786 Dose 2/Q Dose 2 (Drug)
Cohorts H and J
Single dose (D1) followed by twice daily dosing for 7 days
干预措施: AVP-923 (Drug)
结局指标
主要结局
Plasma concentrations of parent and metabolites
时间窗: 8 Days
次要结局
- Safety and tolerability(8 days)