A Randomized, Double-Blind, Placebo and Active-Controlled, Crossover Study in Opioid-Experienced, Non-Dependent Recreational Drug Users to Determine the Abuse Potential and Safety of CL-108 Tablets Administered Via the Oral Route
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Subjective Effects: Maximum Effect (Emax) and Minimum Effect (Emin) of High Visual Analog Scale (VAS) in Dose Selection Phase
研究概览
简要总结
The purpose of this study is to assess the abuse potential of CL-108 tablets, including the abuse deterrent effects of promethazine, following oral administration, relative to hydrocodone/acetaminophen (APAP) tablets and placebo in non-dependent, recreational opioid users.
详细描述
The purpose of this study is to assess the abuse potential of CL-108 tablets, including the abuse deterrent effects of promethazine, following oral administration, relative to hydrocodone/acetaminophen (APAP) tablets and placebo in non-dependent, recreational opioid users; to assess the cognitive and behavioral effects of CL-108 tablets following oral administration relative to hydrocodone/APAP tablets and placebo in non-dependent, recreational opioid users; and to assess the safety of orally administered CL-108 tablets relative to hydrocodone/APAP tablets and placebo in non-dependent, recreational opioid users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •BMI within 18.0 to 33.0 kg/m2, inclusive (minimum weight of 50.0 kg at Screening)
- •Healthy, as determined by no clinically significant medical history, physical examination findings, 12-lead ECG findings, vital signs measurements, and laboratory results at screening, as judged by the investigator
- •Current opioid users who had used oral opioids for recreational (non-therapeutic) purposes, at least 10 times in the past year
排除标准
- •Drug or alcohol dependence within the last 12 months (except nicotine)
- •Subjects who had ever been in treatment for substance use disorders (except smoking cessation
- •History of presence of any clinically significant cardiac, neurologic, pulmonary, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, dermatologic, renal, or other major disease at screening, which in the opinion of the investigator, would have jeopardized the safety of the subject or the validity of the study results
- •History or presence of hypotension, judged to be clinically significant based on investigator judgement
研究组 & 干预措施
Treatment C:M366 22.5mg/975mg
M366 22.5 mg/975 mg tablet by mouth
干预措施: M366 (Drug)
Treatment D: M366 37.5mg/1625mg
M366 37.5 mg/1625 mg tablet by mouth
干预措施: M366 (Drug)
Treatment B:CL-108 37.5mg/1625mg/62.5mg
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
干预措施: CL-108 (Drug)
Treatment A:CL-108 22.5mg/975mg/37.5mg
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
干预措施: CL-108 (Drug)
Treatment E: Placebo
Placebo 0 mg tablet by mouth
干预措施: Placebo (Drug)
结局指标
主要结局
Subjective Effects: Maximum Effect (Emax) and Minimum Effect (Emin) of High Visual Analog Scale (VAS) in Dose Selection Phase
时间窗: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours (post-dose)
High VAS measures the positive effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). For VAS assessment, pre-dose (baseline) value was subtracted from each post-dose value prior to calculation of the pharmacodynamic (PD) parameter. Emax is the largest effect score and Emin is the smallest effect score between 0 to 24 hours post-dose.
Subjective Effects: Emax of Any Effects VAS in Dose Selection Phase
时间窗: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours (post-dose)
Any drug effects VAS measures other subjective effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0 (pre-dose) to 24 hours post-dose.
Emax of Drug Liking VAS in Treatment Phase
时间窗: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 24 hours
Drug liking VAS is the measure 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 (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). Emax is the largest effect score between 0.5 to 24 hours post-dose.
次要结局
- Balance of Effects: Time-averaged Area Under the Effect Curve (TA_AUE) of Drug Liking VAS in Treatment Phase(0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours)
- Positive Effects: TA_AUE of High VAS in Treatment Phase(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose))
- Negative Effects: TA_AUE of Bad Effects VAS in Treatment Phase(0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours)
- Sedative and Other Effects: TA_AUE of Alertness/Drowsiness VAS in Treatment Phase(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose))
- Number of Adverse Events in Dose Selection Phase(Up to visit 3 (Follow up))
- Balance of Effects: Emin of Drug Liking VAS in Treatment Phase(0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours)
- Balance of Effects: Emax and Emin of Overall Drug Liking VAS in Treatment Phase(0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours)
- Positive Effects: Emax of Good Effects VAS in Treatment Phase(0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours)
- Positive Effects: TA_AUE of Good Effects VAS in Treatment Phase(0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours)
- Balance of Effects: Emax and Emin of Take Drug Again VAS in Treatment Phase(0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours)
- Positive Effects: Emax of High VAS in Treatment Phase(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose))
- Negative Effects: Emax of Bad Effects VAS in Treatment Phase(0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours)
- Sedative and Other Effects: Emin of Alertness/Drowsiness VAS in Treatment Phase(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose))
- Sedative and Other Effects: Emax of Any Effects VAS in Treatment Phase(0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours)
- Pupillometry: Maximum Pupil Constriction (MPC)(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose))
- Sedative and Other Effects: TA_AUE of Any Effects VAS in Treatment Phase(0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours)
- Objective Measures: Change From Baseline in Choice Reaction Time (CRT) in Treatment Phase(0 (Baseline, pre-dose), 1, 2, 4, 8 and 24 hours (post-dose))
- Change From Baseline in Number of Errors (Any Errors) in CRT Test in Treatment Phase(0 (Baseline, pre-dose), 1, 2, 4, 8 and 24 hours (post-dose))
- Pupillometry: TA_AUE of MPC in Treatment Phase(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose))