Pharmacogenetics of Bupropion Metabolism
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|ClinicalTrials.gov Identifier: NCT00791869|
Recruitment Status : Completed
First Posted : November 17, 2008
Last Update Posted : May 22, 2013
|Condition or disease|
Bupropion is widely used in the treatment of depression and for smoking cessation. It's most abundant metabolite, hydroxybupropion, may be responsible for most of the therapeutic effect of bupropion under conditions of long term dosing. Because the primary enzyme involved in metabolism of bupropion to hydroxybupropion is the liver enzyme CYP2B6, we propose to study the effect of different CYP2B6 genotypes on the metabolism of bupropion. These data will guide the use of genotypes as a surrogate for measuring drug blood levels in studying genetic determinants of outcomes for bupropion treatment.
A minimum of Forty-four subjects with 4 different CYP2B6 genotypes will participate in a 7-day study in which they take bupropion as outpatients for 6 days (to achieve steady state drug levels) and then come to the San Francisco General Hospital (SFGH) Clinical Research Center for a 1-day admission during which multiple blood and urine samples will be collected for pharmacokinetic analysis.
|Study Type :||Observational|
|Actual Enrollment :||43 participants|
|Official Title:||Pharmacogenetics of Bupropion Metabolism|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||November 2010|
- Area under the plasma concentration versus time curve (AUC) for bupropion [ Time Frame: 0, 4, 8, 12, 16,24 hours from steady state ]Subjects took bupropion daily for 7 days as outpatients prior to the study day to allow them to reach steady state concentrations of bupropion and its metabolites. The time frame shown is measured from 08:00 on the morning of inpatient admission.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791869
|United States, California|
|San Francisco General Hospital-Clinical Research Ward|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Neal L Benowitz, MD||University of California, San Francisco|