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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00463918
First received: April 18, 2007
Last updated: November 18, 2008
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Drug: varenicline
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Enrollment: 73
Study Start Date: May 2007
Study Completion Date: December 2007
Intervention Details:
    Drug: varenicline
    Other Name: Chantix, Champix
  Eligibility

Ages Eligible for Study:   12 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463918

Locations
United States, Alabama
Pfizer Investigational Site
Anniston, Alabama, United States, 36201
Pfizer Investigational Site
Anniston, Alabama, United States, 36207
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
United States, Arkansas
Pfizer Investigational Site
Hot Springs, Arkansas, United States, 71913
United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92801
Pfizer Investigational Site
Los Angeles, California, United States, 90211
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511-5473
United States, Florida
Pfizer Investigational Site
DeLand, Florida, United States, 32720
Pfizer Investigational Site
Gainesville, Florida, United States, 32607
United States, Hawaii
Pfizer Investigational Site
Honolulu, Hawaii, United States, 96813
Pfizer Investigational Site
Honolulu, Hawaii, United States, 96826
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
United States, Kentucky
Pfizer Investigational Site
Bardstown, Kentucky, United States, 40004
Pfizer Investigational Site
Lexington, Kentucky, United States, 40509
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78209
United Kingdom
Pfizer Investigational Site
Slough, Berkshire, United Kingdom, SL1 2AD
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00463918     History of Changes
Other Study ID Numbers: A3051070
Study First Received: April 18, 2007
Last Updated: November 18, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014