Status:
COMPLETED
A Phase I Study to Evaluate the Pharmacokinetics of Multiple Doses of Varenicline in Healthy Adolescent Smokers
Lead Sponsor:
Pfizer
Conditions:
Smoking Cessation
Eligibility:
All Genders
12-16 years
Phase:
PHASE1
Brief Summary
This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three ciga...
Eligibility Criteria
Inclusion
- Healthy male and female adolescents (12 - 16 years inclusive) with a total body weight greater than 30 kg who currently smoke an average of at least 3 cigarettes per day.
Exclusion
- Male and female subjects with a positive urine drug screen and female subjects with a positive pregnancy test.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00463918
Start Date
May 1 2007
End Date
December 1 2007
Last Update
November 19 2008
Active Locations (16)
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1
Pfizer Investigational Site
Anniston, Alabama, United States, 36201
2
Pfizer Investigational Site
Anniston, Alabama, United States, 36207
3
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
4
Pfizer Investigational Site
Hot Springs, Arkansas, United States, 71913