Clinical Trial: Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Acetaminophen Adduct Formation in Alcohol Abstaining Subjects Administered Therapeutic Doses of Acetaminophen for Ten Consecutive Days

Brief Summary: Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by processing it in the liver. During the processing, some of the acetaminophen may bind to proteins in the liver. The protein-acetaminophen product is called an "adduct." After a large acetaminophen overdose, the liver has to process a lot of acetaminophen, so large amounts of adducts are formed. However, we have found that lower levels may be formed even when people take recommended doses. The purpose of this study is to measure the amount of adducts formed when healthy people who do not drink alcohol take normal doses of acetaminophen for 10 days.

Detailed Summary:
Sponsor: Kennon Heard

Current Primary Outcome: Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts [ Time Frame: Day 0, 4, 7, 9, 11, and 14. ]

Acetaminophen-cysteine (APAP-Cys) protein adduct concentrations were measured at Day 0, 4, 7, 9, 11 and 14. All units are in nmol/mL serum.


Original Primary Outcome: serum level of APAP-Cys protein adducts [ Time Frame: before, during and following 10 days of therapy ]

Current Secondary Outcome: Alanine Aminotransferase (ALT) [ Time Frame: Day 0, 4, 7, 9, 11, and 14. ]

ALT was measured at Day 0, 4, 7, 9, 11, and 14.


Original Secondary Outcome: Alanine Aminotransferase (ALT) [ Time Frame: before, during and following 10 days of therapy ]

Information By: Denver Health and Hospital Authority

Dates:
Date Received: February 4, 2008
Date Started: August 2007
Date Completion:
Last Updated: July 10, 2012
Last Verified: July 2012