NCT03657355已完成1 期
Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, 6-way Cross-over Study to Evaluate the Abuse Potential of Single, Oral Doses of ACT-541468 in Healthy Recreational Drug Users
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Maximum effect (Emax) of the Drug Liking VAS ('at this moment') over 24 h post-dose during each treatment period
研究概览
简要总结
This placebo- and active controlled study will investigate the abuse potential of ACT-541468 in healthy recreational drug users
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)
盲法说明
For blinding purposes, suvorexant and zolpidem will be over-encapsulated, whereas a matching-placebo will be used for ACT-541468.
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
- •Signed informed consent prior to any study-mandated procedure
- •Male or female healthy subjects, 18-55 years of age (inclusive) at Screening
- •Body mass index of 18.0-33.0 kg/m2 (inclusive) at Screening and a minimum weight of 50.0 kg at Screening
- •Current sedative users who have used sedatives (e.g., benzodiazepines, zolpidem, eszopiclone, gamma-hydroxybutyrate, barbiturates) for recreational (non-therapeutic) purposes (i.e., for psychoactive effects) at least ten times in their life and at least once in the 12 weeks before Screening
- •Women of childbearing potential must consistently and correctly use a reliable method of contraception with a failure rate of < 1% per year, be sexually inactive, or have a vasectomized partner
- •Women of non-childbearing potential
- •Male subjects are required to use a medically acceptable method of contraception throughout the entire study period and for at least 90 days after last study drug administration
排除标准
- •History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment(s)
- •Positive HIV or hepatitis B/C test at Screening
- •Female subjects who are currently pregnant or lactating or who are planning to become pregnant within 1 month of the last study treatment administration
- •Modified Swiss Narcolepsy Scale total score < 0 at Screening or history of narcolepsy or cataplexy
- •Substance or alcohol dependence within 2 years prior to Screening or prior participation in a substance or alcohol dependence rehabilitation program
- •Subjects who have a positive urine drug screen at admittance to the qualification or core phase
- •Any sleep-disorder including self-reported insomnia disorder, breathing-related sleep disorders, restless legs syndrome (RLS), nightmare disorder, non-rapid eye movement (REM), sleep arousal disorders, REM sleep behavior disorder, circadian rhythm sleep-wake disorders, or narcolepsy
- •Any of the following SLEEP-50 Questionnaire scores at Screening:
- •≥ 15 on Apnea subscale;
- •≥ 7 on Narcolepsy subscale;
- •≥ 7 on RLS or Periodic limb movement disorder subscale;
- •≥ 8 on Circadian Rhythm subscale;
- •≥ 7 on Sleepwalking subscale;
- •≥ 3 on Item 32 and ≥ 9 on Items 33 to 35 (i.e., on nightmare subscale);
- •≥ 15 on Impact subscale.
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo will be administered as tablets for oral use.
干预措施: Placebo (Drug)
50 mg ACT-541468
Experimental
ACT-541468 will be administered as tablets for oral use.
干预措施: ACT-541468 (Drug)
100 mg ACT-541468
Experimental
ACT-541468 will be administered as tablets for oral use.
干预措施: ACT-541468 (Drug)
150 mg ACT-541468
Experimental
ACT-541468 will be administered as tablets for oral use.
干预措施: ACT-541468 (Drug)
150 mg suvorexant
Active Comparator
Suvorexant will be administered as tablets for oral use.
干预措施: Suvorexant (Drug)
30 mg zolpidem
Active Comparator
Zolpidem will be administered as tablets for oral use.
干预措施: Zolpidem (Drug)
结局指标
主要结局
Maximum effect (Emax) of the Drug Liking VAS ('at this moment') over 24 h post-dose during each treatment period
时间窗: Duration: for up to 24 hours post-dose
VAS = visual analogue scale
次要结局
- Drug Liking VAS (bipolar)(Duration: for up to 24 hours post-dose)
- Overall Drug Liking VAS (bipolar)(Duration: for up to 12 hours post-dose)
- Take Drug Again VAS (bipolar)(Duration: for up to 12 hours post-dose)
- Good Effects VAS (unipolar)(Duration: for up to 24 hours post-dose)
- Drug Similarity VAS(Duration: for up to 1 hour post-dose)
- Bad Effects VAS (unipolar)(Duration: for up to 24 hours post-dose)
- Alertness/Drowsiness VAS (bipolar)(Duration: for up to 24 hours post-dose)
- Any Effects VAS (unipolar)(Duration: for up to 24 hours post-dose)
- Feeling High VAS (unipolar)(Duration: for up to 24 hours post-dose)
- Bowdle VAS Internal and External Perceptions(Duration: for up to 24 hours post-dose)
- Observer's Assessment of Alertness/Sedation composite and sum scores(Duration: for up to 24 hours post-dose)
- Reaction time task score(Duration: for up to 8 hours post-dose)
- Rapid visual information processing score(Duration: for up to 8 hours post-dose)
- Paired Associates Learning score(Duration: for up to 8 hours post-dose)
研究者
研究点 (2)
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