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AFQ065

Phase 1

Smoking Abstinence | Small molecule | Psychiatry |Novartis AG|Last Updated: Jun 22, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

AFQ065 · 1 trial · 1 indication

Phase 1 1
NCT00414752Effects of AFQ056 and Nicotine in Reducing Cigarette SmokingSmoking Abstinence
COMPLETED36 Analytics
PHASE1COMPLETED
Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking
Smoking AbstinenceUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
AFQ065DRUG -
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 th...

Countries:Germany
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Frequently asked questions about AFQ065

What is AFQ065 used for?

AFQ065 is an investigational small molecule being studied for smoking abstinence, a psychiatry indication. It is being developed by Novartis AG (NVS). The drug is currently in Phase 1 clinical development and is not approved by the FDA.

Who makes AFQ065?

AFQ065 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The drug is an investigational small molecule in Phase 1 clinical development for smoking abstinence.

What phase is AFQ065 in?

AFQ065 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and the drug is not currently in any active clinical trials.

What clinical trials is AFQ065 in?

AFQ065 has one completed Phase 1 clinical trial, identified as NCT00414752, titled "Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking." The trial enrolled 36 participants in Germany and was a randomized, double-blind, uncontrolled study involving healthy volunteers.

Is AFQ065 the same as AFQ056?

The completed clinical trial for AFQ065, NCT00414752, is titled "Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking," which suggests AFQ065 may be related to or the same as AFQ056. However, the drug is listed as AFQ065 in the trial record.