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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Smoking Cessation

Treatments: Drug: varenicline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00463918

A3051070

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 12 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind