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Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking

NCT ID: NCT00414752

Last Updated: 2007-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

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.

Detailed Description

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Conditions

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Smoking Abstinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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AFQ065

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis

Role: PRINCIPAL_INVESTIGATOR

Investigator site

Locations

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Novartis Investigative Site

Nuremberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CAFQ056A2109

Identifier Type: -

Identifier Source: org_study_id