Multiple Dose, Dose Escalation Study of Varenicline Controlled Release Formulation in Adult Smokers

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

February 29, 2008

Study Completion Date

February 29, 2008

Conditions
Smoking Cessation
Interventions
DRUG

Varenicline Tartrate

Varenicline 1.8 mg AMT-8 controlled release tablets administered twice a day for 14 days.

DRUG

Varenicline Tartrate

Planned dose is Varenicline 2.4 mg AMT-8 controlled release tablets administered twice a day for 14 days. Actual dose may be adjusted based on emerging data from prior dose cohorts.

DRUG

Varenicline Tartrate

Planned dose is Varenicline 3 mg AMT-8 controlled release tablets administered twice a day for 14 days. Actual dose may be adjusted based on emerging data from prior dose cohorts.

DRUG

Varenicline Tartrate

The dose to be administered is not yet determined and will be based on emerging data from prior dose cohorts. The dose will be administered as Varenicline AMT-8 controlled release tablets twice a day for 14 days. The doses to be tested may be lower, higher or repeat a previously tested dose and may include a titration.

DRUG

Varenicline Tartrate

The dose to be administered is not yet determined and will be based on emerging data from prior dose cohorts. The dose will be administered as Varenicline AMT-8 controlled release tablets twice a day for 14 days. The doses to be tested may be lower, higher or repeat a previously tested dose and may include a titration.

Trial Locations (2)

58104

Pfizer Investigational Site, Fargo

58721

Pfizer Investigational Site, East Grand Forks

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY