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

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Slough, Berkshire, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Varenicline

Drug

Other names: Chantix, Champix

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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability of Varenicline in Healthy Adolescent Smokers

Important dates

Study start: 2007
Study completion: 2007
First posted: Apr 20, 2007
Registry last updated: Nov 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed