Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days
Information source: Denver Health and Hospital Authority
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Drug Induced Liver Injury
Intervention: acetaminophen (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Denver Health and Hospital Authority Official(s) and/or principal investigator(s):
Kennon Heard, MD, Principal Investigator, Affiliation: Denver Health/Rocky Mountain Poison & Drug Center
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.
Clinical Details
Official title: Acetaminophen Adduct Formation in Alcohol Abstaining Subjects Administered Therapeutic Doses of Acetaminophen for Ten Consecutive Days
Study design: Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: serum level of APAP-Cys protein adducts
Secondary outcome: alanine aminotransferase (ALT)
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. age 21 years or older
2. provide written informed consent
3. consume, on average, less than 1 alcoholic beverage daily for the previous 3 months
and would be considered non-drinkers
Exclusion Criteria:
1. History of ingesting more than 4 grams of acetaminophen per day for any of the four
days preceding study enrollment
2. Currently taking isoniazid
3. Consumption of any alcoholic beverage during the run-in period
4. A detectable serum acetaminophen at baseline
5. Serum ALT or AST levels greater than 50 IU/L at the start of the run-in period or at
baseline
6. Platelet count less than 125,000/cc at baseline
7. Positive pregnancy test at baseline (female participants only)
8. Currently adheres to a fasting type diet as determined by self report
9. Currently has anorexia nervosa as determined by self report
10. Subject appears clinically intoxicated, psychiatrically impaired or unable to give
informed consent for any reason
11. Known hypersensitivity to acetaminophen
Locations and Contacts
Denver Health Rocky Mountain Poison and Drug Center, Denver, Colorado 80204, United States
Additional Information
Starting date: August 2007
Ending date: January 2008
Last updated: February 4, 2008
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