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

Pfizer73 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Smoking Cessation

Interventions

vareniclineDRUG

Eligibility

Sex: ALLMin age: 12 YearsMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (16)

Pfizer Investigational Site

Anniston, Alabama, United States

Pfizer Investigational Site

Anniston, Alabama, United States

Outcomes

Primary Outcomes

Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).

Secondary Outcomes

Pharmacokinetic parameters: Individual predicted estimates of Cmax, Tmax, and AUCτ on Day 14 (steady-state) using the final PK model and individual post-hoc estimates of the PK parameters.

Data from ClinicalTrials.gov

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