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OpenTrials
Completed

NCT Number: NCT00414752

Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking

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.

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Key information

Conditions

Smoking Abstinence Behavior Smoking

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site

Nuremberg, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AFQ065

Drug

Primary outcomes

  1. Reduction of craving by self-report questionnaires during 3 days of voluntary smoking stoppage

Secondary outcomes

  1. Reduction in symptoms of withdrawal during 3 days of voluntary smoking stoppage

  2. Reduction in nicotine consumption during 6 days of free smoking

  3. Reduction in impulsivity during 3 days of free smoking and during 3 days of voluntary smoking stoppage

  4. Reduction in craving during 6 days of free smoking

  5. Safety and tolerability of AFQ056 during treatment periods

  6. Assessment of how the body interacts with AFQ056

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2006
First posted
Dec 22, 2006
Registry last updated
Jun 22, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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