Conditions: Pain Fever Hepatotoxicity
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 95
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: 2 x 500 mg acetaminophen by mouth once arm 2: 2 x 500 mg acetaminophen by mouth once

Interventions: intervention 1: Acetaminophen
Intervention descriptions: intervention 1: 2 x 500 mg by mouth once

Protocol document: