NCT00768716

Effect of Race/Ethnicity and Genes on Acetaminophen Pharmacokinetics

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Tufts University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pain
• Fever
• Hepatotoxicity

Interventions

Type	Name	Description
DRUG	Acetaminophen	2 x 500 mg by mouth once

Timeline

• Start date: 2008-12-01
• Primary completion: 2012-06-01
• Completion: 2013-12-01
• First posted: 2008-10-08
• Last updated: 2019-05-23
• Results posted: 2019-05-08

Locations

1 site across 1 country: United States