NCT03152123已完成1 期
A Randomized, Double-Blind, Active- and Placebo-Controlled, Single-Dummy, 4-Way Crossover Study to Determine the Abuse Potential of Pitolisant Compared to Phentermine and Placebo, in Healthy, Non-Dependent Recreational Stimulant 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
- 发起方
- Bioprojet
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Maximum effect (Emax) on Drug Liking visual analog scale (VAS)
研究概览
简要总结
The purpose of this study is to assess the abuse potential of single doses of pitolisant relative to phentermine HCl and placebo, when administered to healthy, non-dependent, recreational stimulant 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
- 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 male or female subjects 18 to 55 years of age, inclusive.
- •Must understand and provide written informed consent, prior to the initiation of any protocol-specific procedures.
- •Current stimulant users who have used stimulants for recreational (non-therapeutic) purposes, (ie, for psychoactive effects) at least 10 times in the past year and used stimulants at least 1 time in the 8 weeks before Screening.
- •Female subjects of childbearing potential with male sexual partners must be using and willing to continue using medically acceptable contraception for at least 1 month prior to Screening (at least 3 months for oral and transdermal contraceptives) and for at least 1 month after last study drug administration.
- •Male subjects with female sexual partners of childbearing potential must be using and willing to continue using medically acceptable contraception from Screening and for at least 1 month after the last study drug administration.
- •Able to speak, read, and understand English sufficiently to allow completion of all study assessments.
排除标准
- •Substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years, as defined by the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition - Text Revision (DSM IV-TR), and/or has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence.
- •History or presence of clinically significant abnormality as assessed by physical examination, medical history, vital signs, or laboratory values, which in the opinion of the investigator would jeopardize the safety of the subject or the validity of the study results.
- •History or presence of motor tics, Tourette's syndrome, or significant anxiety, tension, or agitation.
- •Presence of thyrotoxicosis, advanced arteriosclerosis, glaucoma, pheochromocytoma, acid related gastric disorders, or peripheral vasculopathy (including Raynaud's phenomenon).
- •History or presence of cardiovascular disorder (eg, moderate to severe hypertension, angina, arterial occlusive disease, heart failure, hemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies [disorders caused by the dysfunction of ion channels]), or other serious cardia problems.
- •History or presence of CNS abnormalities (eg, cerebral aneurysm, vascular abnormalities, stroke), seizures, convulsions, or epilepsy.
- •History or presence of clinically significant abnormality as assessed by ECG, long QTc syndrome (eg, syncope or arrhythmia), or presence QTcF interval >450 msec.
- •Evidence of clinically significant hepatic or renal impairment including alanine aminotransferase or aspartate aminotransferase > 1.5 × the upper limit of normal (ULN) or bilirubin > 1 × ULN.
- •Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
- •History of allergy or hypersensitivity to pitolisant, phentermine HCl, or related drugs (eg, sympathomimetic amines) or known excipients of any of the drug products in this study (eg, lactose).
- •History of severe allergic reaction (including anaphylaxis) to any substance or previous status asthmaticus.
- •Subjects with any history of suicidal ideation or suicidal behavior, as assessed by the C SSRS (baseline version).
- •Treatment with an investigational drug within 5 times the elimination half-life, if known (eg, a marketed product), or within 30 days (if the elimination half-life is unknown) prior to the first study drug administration or is concurrently enrolled in any research, judged not to be scientifically or medically compatible with this study.
研究组 & 干预措施
Pitolisant HCl, 40 mg
Experimental
Pitolisant HCl, 40 mg administered as 2 capsules, each containing 1 × 20 mg pitolisant HCl tablet (over-encapsulated), and 2 capsules, each containing 1 × 100 mg lactose tablet (over-encapsulated)
干预措施: Pitolisant (Drug)
Pitolisant HCl, 240 mg
Experimental
Pitolisant HCl, 240 mg administered as 4 capsules, each containing 60 mg pitolisant HCl (3 x 20 mg pitolisant HCl tablets, encapsulated in 1 capsule)
干预措施: Pitolisant (Drug)
Phentermine HCl, 60 mg
Active Comparator
Phentermine HCl, 60 mg administered as 2 capsules, each containing 1 × 30 mg phentermine HCl capsule (over- encapsulated), and 2 capsules, each containing 1 × 100 mg lactose tablet (over-encapsulated)
干预措施: Phentermine (Drug)
Placebo
Placebo Comparator
Placebo administered as 4 capsules, each containing 1 × 100 mg lactose tablet (over-encapsulated)
干预措施: Placebos (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
- Drug Liking VAS (minimum effect [Emin] and time-averaged area under the effect curve to 24 hours after study drug administration [TA_AUE])(Within 24 hours post-dose)
- Overall Drug Liking VAS (Emax/Emin)(Within 24 hours post-dose)
- Good Effects VAS (Emax and TA_AUE)(Within 24 hours post-dose)
- Safety and tolerability of Pitolisan HCl as assessed by AEs(Up to 6 weeks)
- Safety and tolerability of Pitolisan HCl by laboratory assessments(Up to 6 weeks)
- Safety and tolerability of Pitolisan HCl as assessed by 12-lead ECGs(Up to 6 weeks)
- Safety and tolerability of Pitolisan HCl as assessed by vital signs(Up to 6 weeks)
- Safety and tolerability of Pitolisan HCl as assessed by physical examination(Up to 6 weeks)
- Take Drug Again VAS (Emax)(Within 24 hours post-dose)
- Bad Effects VAS (Emax and TA_AUE)(Within 24 hours post-dose)
- ARCI-BG scale (Emax and TA_AUE)(Within 24 hours post-dose)
- ARCI-A scale (Emax and TA_AUE)(Within 24 hours post-dose)
- Agitation/Relaxation VAS (Emax and TA_AUE)(Within 24 hours post-dose)
- Drug Similarity VAS (score at 24 hours after study drug administration)(Within 24 hours post-dose)
研究者
研究点 (1)
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