Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking

Tracking Information
First Submitted Date ICMJE	December 21, 2006
First Posted Date ICMJE	December 22, 2006
Last Update Posted Date	June 22, 2007
Study Start Date ICMJE	September 2006
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: December 21, 2006)	Reduction of craving by self-report questionnaires during 3 days of voluntary smoking stoppage
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00414752 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 21, 2006)	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
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking
Official Title ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double; Primary Purpose: Treatment
Condition ICMJE	Smoking Abstinence
Intervention ICMJE	Drug: AFQ065
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: December 21, 2006)	36
Original Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 60 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Germany
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00414752
Other Study ID Numbers ICMJE	CAFQ056A2109
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Novartis
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Novartis Investigator site
PRS Account	Novartis
Verification Date	June 2007
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP