Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking

Novartis

Status and phase

Completed

Phase 1

Conditions

Smoking Abstinence

Treatments

Drug: AFQ065

Study type

Interventional

Funder types

Industry

Identifiers

NCT00414752

CAFQ056A2109

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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