NCT00414752

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed
Last Updated

June 22, 2007

Status Verified

June 1, 2007

First QC Date

December 21, 2006

Last Update Submit

June 21, 2007

Conditions

Smoking Abstinence

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Interventions

AFQ065DRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Nuremberg, Germany

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Novartis

    Investigator site

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 21, 2006

First Posted

December 22, 2006

Study Start

September 1, 2006

Last Updated

June 22, 2007

Record last verified: 2007-06

Locations

DE(1)