NCT00414752已完成1 期
A Randomized, Double Blind, Multiple Dose, Cross-Over, Placebo- and Active-Controlled Proof of Concept Study to Explore the Effects of AFQ056 and Nicotine (Active Comparator) on Craving and Withdrawal During Voluntary Smoking Abstinence in Healthy Smokers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Reduction of craving by self-report questionnaires during 3 days of voluntary smoking stoppage
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of AFQ056 and nicotine compared to placebo on craving and withdrawal symptoms during voluntary smoking stoppage in healthy smokers. This study will also assess how the body interacts with AFQ056.
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, male & female subjects at least 18 years and ≤60 years of age
- •In good health
- •Female subjects must be surgically sterilized or postmenopausal.
- •Current smokers not intending to quit
- •Smoke on average 15 cigarettes or more and less than 60 cigarettes a day for the past year
- •Fagerström Test for Nicotine Dependence score of at least 5 (indicates moderate to heavy smokers)
- •Willing to refrain from smoking as required
- •Written informed consent before entering the study
排除标准
- •History of heart disease, septum defect and/or cardiac valves surgery; clinical relevant abnormality in the ECG
- •Investigational drug treatment within 4 weeks prior to screening unless local health authority guidelines mandate a longer period
- •Women of childbearing potential, pregnant or lactating females
- •Donation of one unit (400mL) or more of blood, significant blood loss equaling at least one unit of blood within the past 2 months or a blood transfusion within 8 weeks prior to screening.
- •Coffee consumption of more than 6 cups coffee/day
- •Use of a medication within 2 weeks prior to Day 1 of each treatment period
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Reduction of craving by self-report questionnaires during 3 days of voluntary smoking stoppage
次要结局
- Reduction in symptoms of withdrawal during 3 days of voluntary smoking stoppage
- Reduction in nicotine consumption during 6 days of free smoking
- Reduction in impulsivity during 3 days of free smoking and during 3 days of voluntary smoking stoppage
- Reduction in craving during 6 days of free smoking
- Safety and tolerability of AFQ056 during treatment periods
- Assessment of how the body interacts with AFQ056
研究者
研究点 (1)
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