Viewing Study NCT00768716



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Study NCT ID: NCT00768716
Status: COMPLETED
Last Update Posted: 2019-05-23
First Post: 2008-10-07

Brief Title: Effect of RaceEthnicity and Genes on Acetaminophen Pharmacokinetics
Sponsor: Tufts University
Organization: Tufts University

Study Overview

Official Title: Effect of RaceEthnicity and Genes on Acetaminophen Pharmacokinetics
Status: COMPLETED
Status Verified Date: 2019-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Although acetaminophen is the most commonly used nonprescription drug in the USA little is known regarding the influence of genes and raceethnicity 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 n100 and African-Americans n100 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: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01GM102130 NIH None httpsreporternihgovquickSearchR01GM102130
R01GM061834 NIH None None