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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00414752

Enrollment

Registered

2006-12-22

Start date

2006-09-30

Completion date

Unknown

Last updated

2007-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Abstinence

Keywords

Smoking, abstinence, craving, smoker, AFQ056, nicotine, placebo

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.

Interventions

DRUGAFQ065

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

Measure	Time frame
Reduction of craving by self-report questionnaires during 3 days of voluntary smoking stoppage	—

Secondary

Measure	Time frame
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 symptoms of withdrawal during 3 days of voluntary smoking stoppage	—
Safety and tolerability of AFQ056 during treatment periods	—
Assessment of how the body interacts with AFQ056	—
Reduction in craving during 6 days of free smoking	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026