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NCT00463918 Clinical Trial

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

Smoking Cessation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00463918
Other study ID # A3051070
Secondary ID
Status Completed
Phase Phase 1
First received April 18, 2007
Last updated November 18, 2008
Start date May 2007
Est. completion date December 2007

Study information
Verified date November 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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 cigarettes per day.

Recruitment information / eligibility
Status Completed
Enrollment 73
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years to 16 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• varenicline

Locations
Country Name City State
United Kingdom Pfizer Investigational Site Slough Berkshire
United States Pfizer Investigational Site Anaheim California
United States Pfizer Investigational Site Anniston Alabama
United States Pfizer Investigational Site Anniston Alabama
United States Pfizer Investigational Site Bardstown Kentucky
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 Hot Springs Arkansas
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site New Haven Connecticut
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Pharmacokinetic parameters: Individual predicted estimates of Cmax, Tmax, and AUCt on Day 14 (steady-state) using the final PK model and individual post-hoc estimates of the PK parameters.
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