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Effect of Race/Ethnicity and Genes on Acetaminophen Pharmacokinetics

This study has been completed.
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Tufts University
ClinicalTrials.gov Identifier:
NCT00768716
First received: October 7, 2008
Last updated: July 5, 2017
Last verified: July 2017
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    Concentrations of acetaminophen in plasma measured by HPLC


Secondary Outcome Measures:
  • 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


Enrollment: 148
Actual Study Start Date: December 2008
Study Completion Date: December 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: White subjects
2 x 500 mg acetaminophen by mouth once
Drug: Acetaminophen
2 x 500 mg by mouth once
Other Name: Tylenol
Experimental: Black subjects
2 x 500 mg acetaminophen by mouth once
Drug: Acetaminophen
2 x 500 mg by mouth once
Other Name: Tylenol

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Publications:

Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT00768716     History of Changes
Other Study ID Numbers: 8600
R01GM061834 ( U.S. NIH Grant/Contract )
R01GM102130 ( U.S. NIH Grant/Contract )
Study First Received: October 7, 2008
Last Updated: July 5, 2017

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics

ClinicalTrials.gov processed this record on August 18, 2017