Effect of Race/Ethnicity and Genes on Acetaminophen Pharmacokinetics
Completed · Phase 4
Conditions studied: Pain, Fever, Hepatotoxicity
In brief
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.
Key facts
- Study ID
- NCT00768716
- Run by
- Tufts University
- People needed
- 95
- Starts
- 2008-12-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2019-05-23
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- self-declared white/Caucasian
- self-declared African-American
- active
- ambulatory
- no evidence of medical disease
You may not qualify if…
- 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
Where it is running
- Tufts Clinical Pharmacology Study Unit — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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