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Effect of Race/Ethnicity and Genes on Acetaminophen Pharmacokinetics

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by Tufts University.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by:
Tufts University
ClinicalTrials.gov Identifier:
NCT00768716
First received: October 7, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose
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.

Condition Intervention Phase
Pain
Fever
Hepatotoxicity
Drug: Acetaminophen
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effect of Race/Ethnicity and Genes on Acetaminophen Pharmacokinetics

Resource links provided by NLM:


Further study details as provided by Tufts University:

Primary Outcome Measures:
  • Acetaminophen plasma levels [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acetaminophen metabolite levels [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2008
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: White subjects Drug: Acetaminophen
2 x 500 mg oral once
Experimental: Black subjects Drug: Acetaminophen
2 x 500 mg oral once

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768716

Locations
United States, Massachusetts
Tufts Clinical Pharmacology Study Unit
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Michael H Court, BVSc, PhD Tufts University
  More Information