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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00791869 |
The aim of the investigators research is to see if variants in a particular gene (named CYP2B6) affect how the body metabolizes (breaks down) certain medications, including the drug bupropion. Bupropion is widely used in the treatment of depression and for helping people quit smoking. Genes are portions of DNA that code for particular proteins in the body. The investigators are studying the gene that codes for a protein called CYP2B6. Differences in the structure of the gene are called variants and may mean that a person metabolizes a drug faster or slower than a person with a different variant.
Condition |
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Metabolism Pharmacokinetics |
Study Type: | Observational |
Study Design: | Case-Only, Cross-Sectional |
Official Title: | Pharmacogenetics of Bupropion Metabolism |
Estimated Enrollment: | 59 |
Study Start Date: | June 2008 |
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 SFGH CCRC for a 1-day admission during which multiple blood and urine samples will be collected for pharmacokinetic analysis.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Healthy subjects with selected CYP2B6 genotypes.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | University of California, San Francisco ( Neal Benowitz, MD ) |
Study ID Numbers: | H133-31868, U01 DA020830 |
Study First Received: | November 14, 2008 |
Last Updated: | November 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00791869 |
Health Authority: | United States: Institutional Review Board |
bupropion smoking pharmacokinetics Pharmacokinetics of bupropion |
Smoking Dopamine Bupropion |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Dopamine Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |