A Phase I Study to Evaluate the Pharmacokinetics of Multiple Doses of Varenicline in Healthy Adolescent Smokers
Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability of Varenicline in Healthy Adolescent Smokers
1 other identifier
interventional
73
2 countries
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2007
Shorter than P25 for phase_1
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2007
CompletedFirst Posted
Study publicly available on registry
April 20, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedNovember 19, 2008
November 1, 2008
April 18, 2007
November 18, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
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 (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Male and female subjects with a positive urine drug screen and female subjects with a positive pregnancy test.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (16)
Pfizer Investigational Site
Anniston, Alabama, 36201, United States
Pfizer Investigational Site
Anniston, Alabama, 36207, United States
Pfizer Investigational Site
Phoenix, Arizona, 85013, United States
Pfizer Investigational Site
Hot Springs, Arkansas, 71913, United States
Pfizer Investigational Site
Anaheim, California, 92801, United States
Pfizer Investigational Site
Los Angeles, California, 90211, United States
Pfizer Investigational Site
New Haven, Connecticut, 06511-5473, United States
Pfizer Investigational Site
DeLand, Florida, 32720, United States
Pfizer Investigational Site
Gainesville, Florida, 32607, United States
Pfizer Investigational Site
Honolulu, Hawaii, 96813, United States
Pfizer Investigational Site
Honolulu, Hawaii, 96826, United States
Pfizer Investigational Site
Overland Park, Kansas, 66212, United States
Pfizer Investigational Site
Bardstown, Kentucky, 40004, United States
Pfizer Investigational Site
Lexington, Kentucky, 40509, United States
Pfizer Investigational Site
San Antonio, Texas, 78209, United States
Pfizer Investigational Site
Slough, Berkshire, SL1 2AD, United Kingdom
Related Publications (3)
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PMID: 37142273DERIVEDFediuk DJ, Sweeney K, Sahasrabudhe V, McRae T, Byon W. Population pharmacokinetics and exposure-response analyses of varenicline in adolescent smokers. CPT Pharmacometrics Syst Pharmacol. 2021 Jul;10(7):769-781. doi: 10.1002/psp4.12645. Epub 2021 Jun 17.
PMID: 34062053DERIVEDFaessel H, Ravva P, Williams K. Pharmacokinetics, safety, and tolerability of varenicline in healthy adolescent smokers: a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2009 Jan;31(1):177-89. doi: 10.1016/j.clinthera.2009.01.003.
PMID: 19243716DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 18, 2007
First Posted
April 20, 2007
Study Start
May 1, 2007
Study Completion
December 1, 2007
Last Updated
November 19, 2008
Record last verified: 2008-11