A Phase I Study to Evaluate the Pharmacokinetics of Multiple Doses of Varenicline in Healthy Adolescent Smokers

Completed · Phase 1

Conditions studied: Smoking Cessation

In brief

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 cigarettes per day.

Key facts

Study ID

NCT00463918

Run by

Pfizer

People needed

73

Starts

2007-05-01

Expected to finish

2007-12-01

Last updated by the study team

2008-11-19

Who can join

Age: 12 and older, up to 16. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Male and female subjects with a positive urine drug screen and female subjects with a positive pregnancy test.

Where it is running

• Pfizer Investigational Site — Anniston, Alabama, United States
• Pfizer Investigational Site — Anniston, Alabama, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Hot Springs, Arkansas, United States
• Pfizer Investigational Site — Anaheim, California, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — New Haven, Connecticut, United States
• Pfizer Investigational Site — DeLand, Florida, United States
• Pfizer Investigational Site — Gainesville, Florida, United States
• Pfizer Investigational Site — Honolulu, Hawaii, United States
• Pfizer Investigational Site — Honolulu, Hawaii, United States
• Pfizer Investigational Site — Overland Park, Kansas, United States
• Pfizer Investigational Site — Bardstown, Kentucky, United States
• Pfizer Investigational Site — Lexington, Kentucky, United States
• Pfizer Investigational Site — San Antonio, Texas, United States
• Pfizer Investigational Site — Slough, Berkshire, United Kingdom

Full record on ClinicalTrials.gov

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