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Effect of Race/Ethnicity and Genes on Acetaminophen Pharmacokinetics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00768716
First Posted: October 8, 2008
Last Update Posted: July 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Tufts University
October 7, 2008
October 8, 2008
July 7, 2017
December 2008
June 2012   (Final data collection date for primary outcome measure)
Acetaminophen plasma levels [ Time Frame: 2 days ]
Concentrations of acetaminophen in plasma measured by HPLC
Acetaminophen plasma levels [ Time Frame: 2 days ]
Complete list of historical versions of study NCT00768716 on ClinicalTrials.gov Archive Site
  • Acetaminophen plasma metabolite levels [ Time Frame: 2 days ]
    Concentrations of acetaminophen glucuronide and sulfate in plasma measured by HPLC
  • Acetaminophen urine metabolite levels [ Time Frame: 2 days ]
    Concentrations of acetaminophen glucuronide, sulfate, cysteine, glutathione, mercapturate in urine measured by HPLC
  • Genetic polymorphisms [ Time Frame: 2 days ]
    CYP, UGT, and SULT gene polymorphisms assayed using patient DNA
Acetaminophen metabolite levels [ Time Frame: 2 days ]
Not Provided
Not Provided
 
Effect of Race/Ethnicity and Genes on Acetaminophen Pharmacokinetics
Effect of Race/Ethnicity and Genes on Acetaminophen Pharmacokinetics
Although acetaminophen is the most commonly used nonprescription drug in the USA, little is known regarding the influence of genes and race/ethnicity on acetaminophen disposition. The investigators long-term goal is to understand the causes of differences in acetaminophen disposition between people that are the result of genetic variation and ethnicity and may predispose individuals to a higher risk of acetaminophen hepatotoxicity. The aim of this particular study is to measure the rate of elimination of acetaminophen via the 3 main pathways (glucuronidation, sulfation and oxidation) in self-identified White-Americans (n=100) and African-Americans (n=100). These rates will then be correlated with selected genetic polymorphisms in genes encoding enzymes involved in acetaminophen metabolism. Two main hypotheses will be tested: 1. African-Americans eliminate acetaminophen more rapidly by glucuronidation than do White-Americans. 2. Elimination via glucuronidation, sulfation, and oxidation in subjects will be significantly correlated with the presence of polymorphisms in the UGT1A6, SULT1A1, and CYP2E1 genes, respectively.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Pain
  • Fever
  • Hepatotoxicity
Drug: Acetaminophen
2 x 500 mg by mouth once
Other Name: Tylenol
  • Experimental: White subjects
    2 x 500 mg acetaminophen by mouth once
    Intervention: Drug: Acetaminophen
  • Experimental: Black subjects
    2 x 500 mg acetaminophen by mouth once
    Intervention: Drug: Acetaminophen

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
148
December 2013
June 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • self-declared white/Caucasian
  • self-declared African-American
  • active
  • ambulatory
  • no evidence of medical disease

Exclusion Criteria:

  • alcohol use of 3 or more drinks per day
  • HIV or hepatitis (B or C) infection
  • isoniazid
  • disulfiram
  • phenobarbital
  • phenytoin
  • carbamazepine
  • rifampicin
  • valproic acid
  • probenecid
  • St. John's Wort
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00768716
8600
R01GM061834 ( U.S. NIH Grant/Contract )
R01GM102130 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Tufts University
Tufts University
National Institute of General Medical Sciences (NIGMS)
Principal Investigator: Michael H Court, BVSc, PhD Tufts University
Tufts University
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP