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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Page 1 of 4 (16 locations)

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