Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00414752

First Posted: December 22, 2006

Last Update Posted: June 22, 2007

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Novartis

Tracking Information

First Submitted Date ^ICMJE

December 21, 2006

First Posted Date ^ICMJE

December 22, 2006

Last Update Posted Date

June 22, 2007

Start Date ^ICMJE

September 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

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

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

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