Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Smoking Abstinence

Intervention / Treatment
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* Drug: AFQ065


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AFQ065|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of craving by self-report questionnaires during 3 days of voluntary smoking stoppage |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, abstinence, craving, smoker, AFQ056, nicotine, placebo