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Completed

NCT Number: NCT00768716

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.

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Key information

Conditions

Pain Body Temperature Changes Fever Hepatotoxicity Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tufts Clinical Pharmacology Study Unit

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen

Drug

2 x 500 mg by mouth once

Other names: Tylenol

Primary outcomes

  1. Acetaminophen Plasma Clearance Association With Race/Ethnicity

    Time frame: 2 days

    Plasma total clearance of acetaminophen in plasma measured by HPLC

  2. Acetaminophen Glucuronidation Partial Clearance Association With Race/Ethnicity

    Time frame: 2 days

    Acetaminophen glucuronidation partial clearance determined from plasma clearance and urinary metabolite excretion

  3. Acetaminophen Sulfation Partial Clearance Association With Race/Ethnicity

    Time frame: 2 days

    Acetaminophen sulfation partial clearance determined from plasma clearance and urinary metabolite excretion

  4. Acetaminophen Oxidation Partial Clearance Association With Race/Ethnicity

    Time frame: 2 days

    Acetaminophen oxidation partial clearance determined from plasma clearance and urinary metabolite excretion

  5. Acetaminophen Plasma Clearance Association With UGT2B15 Genotype

    Time frame: 2 days

    The association of UGT2B15 genotype with acetaminophen total clearance

  6. Acetaminophen Glucuronidation Partial Clearance Association With UGT2B15 Genotype

    Time frame: 2 days

    The association of acetaminophen glucuronidation partial clearance with UGT2B15 genotype

  7. APAP Plasma Adduct Association With UGT2B15 Genotype

    Time frame: 2 days

    The association of UGT2B15 genotype with APAP plasma adduct concentrations

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Oct 8, 2008
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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