A Study to Evaluate the Abuse Potential of EB-1020 Immediate-Release in Healthy Recreational Stimulant Users
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Maximum effect (Emax) on Drug Liking visual analog scale (VAS)
研究概览
简要总结
This single-center study will be a single-dose, randomized, double-blind, placebo- and active-controlled crossover study with a single inpatient treatment visit. The abuse potential of single oral doses of EB-1020 IR (400 mg, 800 mg) will be compared with that of placebo and d-amphetamine (20 mg, 40 mg; active control) in healthy recreational stimulant users. Subjects will participate in a medical Screening visit (Visit 1), one 4-day inpatient Qualification Phase (Visit 2), one 11-day inpatient Treatment Phase (Visit 3), and a safety Follow-up visit (Visit 4).
详细描述
Subjects will be randomized to 1 of 10 treatment sequences according to a two 5 x 5 William squares design. To maintain blinding, subjects will be required to ingest eight capsules with approximately 240 mL water on each study drug administration day.
Serial pharmacodynamic (PD) evaluations will be conducted up to 24 hours after each study drug administration. Pharmacokinetic (PK) samples will be obtained to confirm exposure to EB-1020. Safety monitoring will include recording of adverse events (AEs), regular assessments of vital signs measurements, 12-lead electrocardiogram (ECG) findings, and continuous telemetry monitoring for at least 3 hours after study drug administration.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects must be healthy male nondependent recreational drug users
- •Subjects must be 18 to 55 years old, inclusive.
- •Subjects must have greater than or equal to 10 lifetime nontherapeutic experiences with central nervous system (CNS) stimulants (e.g., amphetamines, cocaine, methylphenidate), greater than or equal to 1 nontherapeutic use of prescription stimulants within the 12 months prior to Screening, and greater than or equal to 1 nontherapeutic use of a CNS stimulant within the 12 weeks prior to Screening.
排除标准
- •Subjects that are deemed medically unsuitable or unlikely to comply with the study protocol for any reason.
- •Subjects who do not pass Qualification Phase criteria to be eligible for the Treatment Phase.
研究组 & 干预措施
lisdexamfetamine 150 mg
lisdexamfetamine 150 mg, administered as 3 capsules, each containing 1 lisdexamfetamine 50-mg capsule, and 5 matching placebo capsules
干预措施: lisdexamfetamine 150 mg (Drug)
d-amphetamine 40 mg
d-amphetamine 40 mg, administered as 4 capsules, each containing two 5-mg d-amphetamine tablets and 4 matching placebo capsules
干预措施: d-amphetamine 40 mg (Drug)
EB-1020 400 mg
EB-1020 400 mg, administered as four 100-mg IR capsules and 4 matching placebo capsules
干预措施: EB-1020 400 mg (Drug)
EB-1020 800 mg
EB-1020 800 mg, administered as eight 100-mg IR capsules
干预措施: EB-1020 800 mg (Drug)
Placebo
Placebo, administered as 8 matching placebo capsules
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum effect (Emax) on Drug Liking visual analog scale (VAS)
时间窗: within 24 hours post-dose
Drug liking VAS is one of the measures of balance of effects that assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm).
次要结局
- High VAS (Emax and TA_AUE)(within 24 hours post-dose)
- Bad Effects VAS (Emax and TA_AUE)(within 24 hours post-dose)
- ARCI-A scale (Emax and TA_AUE)(within 24 hours post-dose)
- Safety and tolerability of EB-1020 by laboratory assessments(Up to 6 weeks)
- Safety and tolerability of EB-1020 as assessed by vital signs(Up to 6 weeks)
- Good Effects VAS (Emax and TA_AUE)(within 24 hours post-dose)
- Nausea VAS (Emax and TA_AUE)(within 24 hours post-dose)
- ARCI-BG scale (Emax and TA_AUE)(within 24 hours post-dose)
- Drug Similarity VAS (score at 12 hours after study drug administration)(within 24 hours post-dose)
- Drug Liking VAS (minimum effect [Emin] and time-averaged area under the effect curve to 12 hours after study drug administration [TA_AUE])(within 24 hours post-dose)
- Overall Drug Liking VAS (Emax/Emin)(within 24 hours post-dose)
- Take Drug Again VAS (Emax)(within 24 hours post-dose)
- Agitation/Relaxation VAS (Emax and TA_AUE)(within 24 hours post-dose)
- Any Effects VAS (Emax and TA_AUE)(within 24 hours post-dose)
- Safety and tolerability of EB-1020 as assessed by 12-lead ECGs(Up to 6 weeks)
- Alertness/Drowsiness VAS (Emax and TA_AUE)(within 24 hours post-dose)
- Safety and tolerability of EB-1020 as assessed by AEs(Up to 6 weeks)