A Phase 1, Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled, 5-Way Crossover Study Evaluating the Abuse Potential of Soticlestat (TAK-935) in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System Depressant Experience
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Treatment Phase: Drug Liking (Maximum Effect [Emax]) "At This Moment" as Assessed Using Bipolar Visual Analogue Scale (VAS)
研究概览
简要总结
The main aim is to evaluate the relative abuse potential of soticlestat in healthy adults who has used central nervous system (CNS) depressants for recreational nontherapeutic reasons.
详细描述
The drug being tested in this study is called soticlestat. Soticlestat is being tested in healthy participants. This study will assess the relative abuse potential of soticlestat compared to alprazolam and placebo in healthy adult, nondependent recreational drug users with CNS depressant experience. The study will enroll approximately 110 participants. Participants will be randomly (by chance, like flipping a coin) assigned to treatments of the study.
Treatment order will remain undisclosed to the participants and study doctor (unless there is an urgent medical need). This single center trial will be conducted in the United States. Participants will be followed up for up to 7 days after the last dose of study drug for a follow-up assessment. The overall time to participate in this study is approximately 11 weeks.
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
- Double (Participant, Investigator)
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 as determined by the investigator.
- •Current CNS depressant user who has used CNS depressants (example, benzodiazepines, barbiturates, zolpidem, eszopiclone, zopiclone, propofol/fospropofol, gamma-hydroxybutyrate) for recreational, nontherapeutic reasons at least 10 times in their lifetime and at least once in the 12 weeks prior to screening. Participant must also have recreational experience with at least 1 other drug class associated with abuse (example, opioids, stimulants, cannabinoids, hallucinogens, dissociatives) at least 10 times in their lifetime.
- •Body mass index (BMI) of 18.5 to 35.0 kilogram per square meter (kg/m^2), inclusive, and a minimum body weight of 50.0 Kilogram (kg) at screening.
排除标准
- •Self-reported history of drug or alcohol dependence (within the past 1 year, except caffeine or nicotine, prior to the screening visit).
- •Positive alcohol breathalyzer or urine drug screen (UDS) for substances of abuse at admission, excluding tetrahydrocannabinol (THC).
- •Heavy smoker or user of other types of nicotine products (greater than [>] 20 cigarettes equivalent per day).
- •Unable to abstain from smoking for at least 2 hours before and at least 8 hours after dosing.
- •Consumes excessive amounts, defined as greater than 4 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
研究组 & 干预措施
Alprazolam 2 mg
Participants will receive a single oral dose of over encapsulated alprazolam 2 mg.
干预措施: Alprazolam (Drug)
Soticlestat 600 mg
Participants will receive a single oral dose of soticlestat 600 mg.
干预措施: Soticlestat 600 mg (Drug)
Soticlestat 900 mg
Participants will receive a single oral dose of soticlestat 900 mg.
干预措施: Soticlestat 900 mg (Drug)
Placebo
Participants will receive a single oral dose of matching placebo.
干预措施: Placebo (Drug)
Soticlestat 300 mg
Participants will receive a single oral dose of soticlestat 300 milligrams (mg).
干预措施: Soticlestat 300 mg (Drug)
结局指标
主要结局
Treatment Phase: Drug Liking (Maximum Effect [Emax]) "At This Moment" as Assessed Using Bipolar Visual Analogue Scale (VAS)
时间窗: Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose
Drug liking ("at this moment") assessed how much a participant likes or dislikes a drug effect at the time the question was being asked. It was scored using a 0 to 100-point bipolar VAS, where 0: Strong disliking, 50: Neither like nor dislike (neutral point), 100: Strong liking. A higher score indicates stronger liking.
次要结局
- Treatment Phase: Overall Drug Liking (Emax) Assessed Using Bipolar VAS(Day 1 of each Treatment Period: 12 and 24 hours post-dose)
- Treatment Phase: Take Drug Again (Emax) Assessed "Overall" by Using Bipolar VAS(Day 1 of each Treatment Period: 12 and 24 hours post-dose)
- Treatment Phase: Bad Drug Effects (Emax) Assessed "At This Moment" by Using Unipolar VAS(Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose)
- Treatment Phase: Good Drug Effects (Emax) Assessed "At This Moment" by Using Unipolar VAS(Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose)
- Treatment Phase: High (Emax) Assessed "At This Moment" by Using Unipolar VAS(Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose)
- Treatment Phase: Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)(From start of study drug administration (Day 1) up to Day 37)