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临床试验/NCT03158025
NCT03158025已完成1 期

A Randomized, Double-Blind, 6-Way Crossover Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users

Eisai Inc.1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2017年4月19日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
Eisai Inc.
入组人数
39
试验地点
1
主要终点
Mean peak Maximum Effect (Emax) score for Drug Liking on a Visual Analog Scale (VAS)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary purpose of this study is to evaluate the abuse potential of lemborexant (E2006) in comparison to placebo and 2 controls with known abuse potential (ie, zolpidem and suvorexant) with similar indications (zolpidem and suvorexant) or mechanisms of action (suvorexant).

详细描述

This is a single-center, single oral dose, randomized, double-blind, placebo-controlled, 6-way crossover study in healthy, non-dependent recreational sedative 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)

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Placebo, LEM 10 mg, SUV 40 mg, LEM 20 mg, ZOL 30 mg, LEM 30 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: Placebo (3 × placebo lemborexant [LEM] tablets; 3 × placebo zolpidem [ZOL] tablets; 2 × placebo suvorexant [SUV], over-encapsulated); LEM 10 milligrams (mg) (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Zolpidem tablets (Drug)

Placebo, LEM 10 mg, SUV 40 mg, LEM 20 mg, ZOL 30 mg, LEM 30 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: Placebo (3 × placebo lemborexant [LEM] tablets; 3 × placebo zolpidem [ZOL] tablets; 2 × placebo suvorexant [SUV], over-encapsulated); LEM 10 milligrams (mg) (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Suvorexant tablets, over-encapsulated (Drug)

LEM 10 mg, LEM 20 mg, Placebo, LEM 30 mg, SUV 40 mg, ZOL 30 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Placebo zolpidem (Drug)

Placebo, LEM 10 mg, SUV 40 mg, LEM 20 mg, ZOL 30 mg, LEM 30 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: Placebo (3 × placebo lemborexant [LEM] tablets; 3 × placebo zolpidem [ZOL] tablets; 2 × placebo suvorexant [SUV], over-encapsulated); LEM 10 milligrams (mg) (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Lemborexant tablets (Drug)

Placebo, LEM 10 mg, SUV 40 mg, LEM 20 mg, ZOL 30 mg, LEM 30 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: Placebo (3 × placebo lemborexant [LEM] tablets; 3 × placebo zolpidem [ZOL] tablets; 2 × placebo suvorexant [SUV], over-encapsulated); LEM 10 milligrams (mg) (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Placebo lemborexant (Drug)

Placebo, LEM 10 mg, SUV 40 mg, LEM 20 mg, ZOL 30 mg, LEM 30 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: Placebo (3 × placebo lemborexant [LEM] tablets; 3 × placebo zolpidem [ZOL] tablets; 2 × placebo suvorexant [SUV], over-encapsulated); LEM 10 milligrams (mg) (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Placebo zolpidem (Drug)

Placebo, LEM 10 mg, SUV 40 mg, LEM 20 mg, ZOL 30 mg, LEM 30 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: Placebo (3 × placebo lemborexant [LEM] tablets; 3 × placebo zolpidem [ZOL] tablets; 2 × placebo suvorexant [SUV], over-encapsulated); LEM 10 milligrams (mg) (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Placebo suvorexant (Drug)

LEM 10 mg, LEM 20 mg, Placebo, LEM 30 mg, SUV 40 mg, ZOL 30 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Zolpidem tablets (Drug)

LEM 10 mg, LEM 20 mg, Placebo, LEM 30 mg, SUV 40 mg, ZOL 30 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Suvorexant tablets, over-encapsulated (Drug)

LEM 10 mg, LEM 20 mg, Placebo, LEM 30 mg, SUV 40 mg, ZOL 30 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Lemborexant tablets (Drug)

LEM 10 mg, LEM 20 mg, Placebo, LEM 30 mg, SUV 40 mg, ZOL 30 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Placebo lemborexant (Drug)

LEM 10 mg, LEM 20 mg, Placebo, LEM 30 mg, SUV 40 mg, ZOL 30 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Placebo suvorexant (Drug)

LEM 20 mg, LEM 30 mg, LEM 10 mg, ZOL 30 mg, Placebo, SUV 40 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Zolpidem tablets (Drug)

LEM 20 mg, LEM 30 mg, LEM 10 mg, ZOL 30 mg, Placebo, SUV 40 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Suvorexant tablets, over-encapsulated (Drug)

LEM 20 mg, LEM 30 mg, LEM 10 mg, ZOL 30 mg, Placebo, SUV 40 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Lemborexant tablets (Drug)

LEM 20 mg, LEM 30 mg, LEM 10 mg, ZOL 30 mg, Placebo, SUV 40 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Placebo lemborexant (Drug)

LEM 20 mg, LEM 30 mg, LEM 10 mg, ZOL 30 mg, Placebo, SUV 40 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Placebo zolpidem (Drug)

LEM 20 mg, LEM 30 mg, LEM 10 mg, ZOL 30 mg, Placebo, SUV 40 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Placebo suvorexant (Drug)

LEM 30 mg, ZOL 30 mg, LEM 20 mg, SUV 40 mg, LEM 10 mg, Placebo

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Zolpidem tablets (Drug)

LEM 30 mg, ZOL 30 mg, LEM 20 mg, SUV 40 mg, LEM 10 mg, Placebo

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Suvorexant tablets, over-encapsulated (Drug)

LEM 30 mg, ZOL 30 mg, LEM 20 mg, SUV 40 mg, LEM 10 mg, Placebo

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Lemborexant tablets (Drug)

LEM 30 mg, ZOL 30 mg, LEM 20 mg, SUV 40 mg, LEM 10 mg, Placebo

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Placebo lemborexant (Drug)

LEM 30 mg, ZOL 30 mg, LEM 20 mg, SUV 40 mg, LEM 10 mg, Placebo

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Placebo zolpidem (Drug)

LEM 30 mg, ZOL 30 mg, LEM 20 mg, SUV 40 mg, LEM 10 mg, Placebo

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Placebo suvorexant (Drug)

ZOL 30 mg, SUV 40 mg, LEM 30 mg, Placebo, LEM 20 mg, LEM 10 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Zolpidem tablets (Drug)

ZOL 30 mg, SUV 40 mg, LEM 30 mg, Placebo, LEM 20 mg, LEM 10 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Suvorexant tablets, over-encapsulated (Drug)

ZOL 30 mg, SUV 40 mg, LEM 30 mg, Placebo, LEM 20 mg, LEM 10 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Lemborexant tablets (Drug)

ZOL 30 mg, SUV 40 mg, LEM 30 mg, Placebo, LEM 20 mg, LEM 10 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Placebo lemborexant (Drug)

ZOL 30 mg, SUV 40 mg, LEM 30 mg, Placebo, LEM 20 mg, LEM 10 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Placebo zolpidem (Drug)

ZOL 30 mg, SUV 40 mg, LEM 30 mg, Placebo, LEM 20 mg, LEM 10 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Placebo suvorexant (Drug)

SUV 40 mg, Placebo, ZOL 30 mg, LEM 10 mg, LEM 30 mg, LEM 20 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Zolpidem tablets (Drug)

SUV 40 mg, Placebo, ZOL 30 mg, LEM 10 mg, LEM 30 mg, LEM 20 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Suvorexant tablets, over-encapsulated (Drug)

SUV 40 mg, Placebo, ZOL 30 mg, LEM 10 mg, LEM 30 mg, LEM 20 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Lemborexant tablets (Drug)

SUV 40 mg, Placebo, ZOL 30 mg, LEM 10 mg, LEM 30 mg, LEM 20 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Placebo lemborexant (Drug)

SUV 40 mg, Placebo, ZOL 30 mg, LEM 10 mg, LEM 30 mg, LEM 20 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Placebo zolpidem (Drug)

SUV 40 mg, Placebo, ZOL 30 mg, LEM 10 mg, LEM 30 mg, LEM 20 mg

Experimental

Participants will receive the following treatments (orally) in Treatments Periods 1 through 6, respectively: SUV 40 mg (2 × 20 mg SUV tablets, over-encapsulated; 3 × placebo ZOL tablets; 3 × placebo LEM tablets); placebo (3 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); ZOL 30 mg (3 × 10 mg ZOL tablets; 3 × placebo LEM tablets; 2 × placebo SUV, over-encapsulated); LEM 10 mg (1 × 10 mg LEM tablet; 2 × placebo LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 30 mg (3 × 10 mg LEM tablets; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated); LEM 20 mg (2 × 10 mg LEM tablets; 1 × placebo LEM tablet; 3 × placebo ZOL tablets; 2 × placebo SUV, over-encapsulated). Each treatment period will be separated by a washout interval of at least 14 days.

干预措施: Placebo suvorexant (Drug)

结局指标

主要结局

Mean peak Maximum Effect (Emax) score for Drug Liking on a Visual Analog Scale (VAS)

时间窗: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks)

Analysis is conducted to evaluate abuse potential. Participants will be asked to respond to the following question on a VAS: "At this moment, my liking for this drug is." The VAS will be scored as an integer from 0 (strong disliking) to 100 (strong liking). The neutral point equals 50 and will be labeled with the anchor "neither like nor dislike."

次要结局

  • Mean time-averaged area under the effects curve (TA_AUE) score for Drug Liking on a VAS(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean Emax score for Feeling High on a VAS(Pre-dose; 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean Emax score for Bad Effects on a VAS(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean peak minimum effect (Emin) score for Drug Liking on a VAS(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean Emax score for Overall Drug Liking (Overall, my liking for this drug is) on a VAS(12 (Day 1), 24 (Day 2), and 48 hours (Day 3) post-dose of each treatment cycle (up to 11 weeks))
  • Mean Emax score for Good Effects on a VAS(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean TEmax score for Bad Effects on a VAS(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean TA_AUE score for Bad Effects on a VAS(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean TA_AUE score for Good Effects on a VAS(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean TEmax score for Feeling Stoned on a VAS(Pre-dose; 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean TA_AUE score for Feeling Stoned on a VAS(Pre-dose; 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean TA_AUE score for Feeling High on a VAS(Pre-dose; 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean Emax score for Sedative Effect on a VAS(Pre-dose; 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean time to peak effect (TEmax) score for Drug Liking on a VAS(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean time to peak minimum effect (TEmin) score for Drug Liking on a VAS(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean Emax score for taking the drug again on a VAS(12 (Day 1), 24 (Day 2), and 48 hours (Day 3) post-dose of each treatment cycle (up to 11 weeks))
  • Mean Emax score for Subjective Drug Value (SDV)(12 (Day 1), 24 (Day 2), and 48 hours (Day 3) post-dose of each treatment cycle (up to 11 weeks))
  • Mean TEmax score for Good Effects on a VAS(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean Emax score for Feeling Stoned on a VAS(Pre-dose; 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean TEmax score for Feeling High on a VAS(Pre-dose; 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean TEmax for ARCI PCAG subscale score(1, 2, 4, and 8 hours (all Day 1) post-dose of each treatment cycle (up to 11 weeks))
  • Mean TA_AUE score for Sedative Effect on a VAS(Pre-dose; 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean Emax score for Any Effects on a VAS(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean TA_AUE score for Any Effects on a VAS(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Maximum change from baseline (CFBmax) in Choice Reaction Time (CRT) score (Motor Reaction Time [MRT] subscale score, Recognition Reaction Time [RRT] subscale score, and Total Reaction Time [TRT] subscale score)(Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean TEmax score for Sedative Effect on a VAS(Pre-dose; 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean Emax for Addiction Research Center Inventory (ARCI) Pentobarbital-Chlorpromazine-Alcohol Group (PCAG) subscale score(1, 2, 4, and 8 hours (all Day 1) post-dose of each treatment cycle (up to 11 weeks))
  • Mean TA-AUE for ARCI PCAG subscale score(1, 2, 4, and 8 hours (all Day 1) post-dose of each treatment cycle (up to 11 weeks))
  • Mean TEmax score for Any Effects on a VAS(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean Emax score for Observer's Assessment of Alertness/Sedation (OAA/S): composite and sum scores(Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean TA_AUE score for OAA/S: composite and sum scores(Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean TA_AUE of CRT score (MRT subscale score, RRT subscale score, and TRT subscale score)(Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Minimum change from baseline (CFBmin) of percentage correct response relative to CRT score (MRT subscale score, RRT subscale score, and TRT subscale score)(Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean TA_AUE of percentage correct response relative to CRT score (MRT subscale score, RRT subscale score, and TRT subscale score)(Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • CFBmax in Divided Attention (DA) score (MRT subscale score, RRT subscale score, and TRT subscale score)(Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean TA_AUE of DA score (MRT subscale score, RRT subscale score, and TRT subscale score)(Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • CFBmin of percentage correct response relative to CRT score (MRT subscale score, RRT subscale score, and TRT subscale score)(Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Mean TA_AUE of percentage correct response relative to DA score (MRT subscale score, RRT subscale score, and TRT subscale score)(Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks))
  • Number of participants with any treatment-emergent adverse event (TEAE)(Up to 20 weeks)
  • Number of participants with any treatment-emergent serious adverse event (SAE)(up to 20 weeks)

研究者

发起方
Eisai Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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