Phase 4 N=27

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

Drug Induced Liver Injury

Bottom Line

View on ClinicalTrials.gov: NCT00616018 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2012

Primary outcome: Primary: Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts — 0.0; 0.3; 0.3; 0.4 nmol/mL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: acetaminophen (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Kennon Heard
Primary completion: Jan 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts	0.0; 0.3; 0.3; 0.4; 0.4; 0.2	—
SECONDARY Alanine Aminotransferase (ALT)	24.0; 25.9; 41.3; 41.3; 41.8; 36.1	—

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.

Eligibility Criteria

Inclusion Criteria

age 21 years or older
provide written informed consent
consume, on average, less than 1 alcoholic beverage daily for the previous 3 months and would be considered non-drinkers

Exclusion Criteria

History of ingesting more than 4 grams of acetaminophen per day for any of the 4 days preceding study enrollment
Currently taking isoniazid
Consumption of any alcoholic beverage during the run-in period
A detectable serum acetaminophen at baseline
Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 50 IU/L at the start of the run-in period or at baseline
Platelet count less than 125, 000/cc at baseline
Positive pregnancy test at baseline (female participants only)
Currently adheres to a fasting type diet as determined by self report
Currently has anorexia nervosa as determined by self report
Subject appears clinically intoxicated, psychiatrically impaired or unable to give informed consent for any reason
Known hypersensitivity to acetaminophen

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Data sourced from ClinicalTrials.gov (NCT00616018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.