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Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00414752
First received: December 21, 2006
Last updated: June 21, 2007
Last verified: June 2007
History of Changes

December 21, 2006
June 21, 2007
September 2006
Not Provided
Reduction of craving by self-report questionnaires during 3 days of voluntary smoking stoppage
Same as current
Complete list of historical versions of study NCT00414752 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking
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

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Smoking Abstinence
Drug: AFQ065
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
Not Provided
Not Provided

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00414752
CAFQ056A2109
Not Provided
Not Provided
Novartis
Not Provided
Principal Investigator: Novartis Investigator site
Novartis
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP