A Phase I Study to Evaluate the Pharmacokinetics of Multiple Doses of Varenicline in Healthy Adolescent Smokers
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00463918
First received: April 18, 2007
Last updated: November 18, 2008
Last verified: November 2008
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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
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:
|
Smoking Habits 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 May 23, 2013