A Randomized, Double-Blind, Double-Dummy, Placebo-, Active-Controlled, 4 Period, 4 Way Crossover Study to Evaluate the Abuse Potential of Manipulated Abuse-Deterrent Dextroamphetamine Sulfate Immediate Release (ADAIR) Formulation Compared to Dextroamphetamine Sulfate Immediate Release When Administered Intranasally to Nondependent, Recreational Stimulant Users
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Drug Liking Emax Visual Analog Scale (VAS)
研究概览
简要总结
This is a randomized, double-blind, double-dummy, placebo- and active-controlled 4 period, 4 way crossover study to assess the intranasal abuse potential of manipulated ADAIR formulation in nondependent, recreational stimulant users. The study will consist of an outpatient Screening Visit, an in clinic Qualification Phase, an in-clinic Treatment Phase, and an outpatient Follow-Up visit.
详细描述
VAL-104 is a phase 1, randomized, double-blind, double-dummy, placebo- and active-controlled 4 period, 4 way crossover study to assess the intranasal abuse potential of manipulated ADAIR formulation in nondependent, recreational stimulant users. The study objectives include assessing the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of manipulated ADAIR 30mg when compared to crushed d-amphetamine sulfate and placebo. The primary PD endpoint is mean maximum drug liking (Emax) on a bipolar 100mm visual analog scale.
A total of 64 subjects demonstrating a confirmed positive response to stimulants will enter the treatment phase. Safety will be assess via adverse events, vital signs, ECGs, clinical laboratory tests and Columbia Suicide Severity Rating Scale (C-SSRS).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female volunteers, 18 to 55 years of age inclusive
- •Recreational drug abuse experience (>/= 10 times lifetime abuse of a CNS stimulant, >/= 1 abuse of CNS stimulant in the previous 3 months)
- •Prior intranasal recreational drug abuse experience
- •Body mass index (BMI) 18 to 33 kg/m2 inclusive
排除标准
- •History of any significant disease or disorder
- •History or current diagnosis of substance dependence (excluding caffeine and nicotine)
- •Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator
- •Positive for hepatitis B, hepatitis C or HIV infection
- •Pregnant or lactating women
- •Participation in an investigational drug or device study within the last 30 days prior to Day 1 of the study
- •Confirmed positive drug screening
- •Positive alcohol breath test at screening / any Day -1
- •Heavy smoker (> 20 cigarettes, > 8 pipefuls or > 8 cigars per day)
研究组 & 干预措施
Oral Placebo + Intranasal manipulated ADAIR
Oral Placebo + Intranasal manipulated ADAIR 30 mg
干预措施: ADAIR 10 mg IR tablets (Drug)
Oral Placebo + Intranasal manipulated ADAIR
Oral Placebo + Intranasal manipulated ADAIR 30 mg
干预措施: Placebo (Drug)
Oral Placebo + Intranasal crushed dextroamphetamine sulfate
Oral Placebo + Intranasal crushed dextroamphetamine sulfate IR 30 mg
干预措施: d-amphetamine sulfate (Drug)
Oral Placebo + Intranasal crushed dextroamphetamine sulfate
Oral Placebo + Intranasal crushed dextroamphetamine sulfate IR 30 mg
干预措施: Placebo (Drug)
Oral ADAIR + Intranasal Placebo
Oral ADAIR 30 mg + Intranasal Placebo
干预措施: Placebo (Drug)
Oral Placebo + Intranasal Placebo
Oral Placebo + Intranasal Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Drug Liking Emax Visual Analog Scale (VAS)
时间窗: Up to 24 hours post-dose
Peak effect for drug liking based on bipolar VAS from 0-100 scale
次要结局
- Take Drug Again Emax VAS(Up to 24 hours post dose)
- Plasma concentrations (PK parameters)(Up to 36 hours post dose)
- Overall Drug Liking Emax VAS(Up to 24 hours post dose)
- Safety (adverse events)(Day 1 to Day 18)