Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking

Smoking Abstinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414752
• Other study ID #: CAFQ056A2109
• Status: Completed
• Phase: Phase 1
• First received: December 21, 2006
• Last updated: June 21, 2007
• Start date: September 2006

Study information

• Verified date: June 2007
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Abstinence

Intervention

Drug:
• AFQ065

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Nuernberg

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of craving by self-report questionnaires during 3 days of voluntary smoking stoppage
Secondary	Reduction in symptoms of withdrawal during 3 days of voluntary smoking stoppage
Secondary	Reduction in nicotine consumption during 6 days of free smoking
Secondary	Reduction in impulsivity during 3 days of free smoking and during 3 days of voluntary smoking stoppage
Secondary	Reduction in craving during 6 days of free smoking
Secondary	Safety and tolerability of AFQ056 during treatment periods
Secondary	Assessment of how the body interacts with AFQ056