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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
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date November 14, 2008
First Posted Date November 17, 2008
Last Update Posted Date May 22, 2013
Study Start Date June 2008
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2013)
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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pharmacogenetics of Bupropion Metabolism
Official Title Pharmacogenetics of Bupropion Metabolism
Brief Summary 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.
Detailed Description

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
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy subjects with selected CYP2B6 genotypes.
Condition
  • Metabolism
  • Pharmacokinetics
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 20, 2013)
43
Original Estimated Enrollment
 (submitted: November 14, 2008)
59
Actual Study Completion Date November 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age: 18 - 65 years
  • Gender: Either
  • Ethnic/Racial Group: Any
  • Smoking Status: Both smokers and non-smokers are eligible
  • CYP2B6 genotype: CYP2B6 *1/*1 (11 subjects); *4, *5 and *6 alleles (11 each) [44 subjects total] Up to 15 additional subjects may be studied with genotypes that do not fall into one of the primary groups.

Exclusion Criteria:

  • Medical: Exclude most any chronic illness requiring regular medication.
  • Cardiac: History of angina or other serious heart disease; ECG abnormalities on screening.
  • Hypertension: screening visit BP of 150/95 or more after 5 min rest
  • Respiratory: Asthma - acceptable if in remission, otherwise exclude.
  • Systemic: "Morbidly Obese" Exclude if BMI > 35
  • Diabetes: By history
  • Chronic Active Hepatitis: By history; elevated Liver Function Tests
  • Cancers: By history
  • Pregnancy/breastfeeding: By history; positive urine pregnancy test
  • Seizures: individuals with a history of seizures will be excluded (risk factor for bupropion-induced seizures)
  • Eating Disorders: individuals with a history of eating disorders will be excluded (risk factor for bupropion-induced seizures)
  • Head Trauma: individuals with a history of head trauma will be excluded (risk factor for bupropion-induced seizures)
  • Other tobacco users (pipe, cigar, chewing tobacco, snuff users
  • Medications/Supplements: General Exclusion = "any regular oral and/or prescription drug use"; current use of oral contraceptives or other female hormones.
  • Drug/alcohol use: no alcohol abuse by history, no regular recreational drug use, any intravenous drug abuse, recent history of Treatment program
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00791869
Other Study ID Numbers H133-31868
U01DA020830 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators Not Provided
Investigators
Principal Investigator: Neal L Benowitz, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date May 2013