Title
Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days
Acetaminophen Adduct Formation in Alcohol Abstaining Subjects Administered Therapeutic Doses of Acetaminophen for Ten Consecutive Days
Phase
Phase 4Lead Sponsor
Denver Health and Hospital AuthorityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Drug Induced Liver InjuryIntervention/Treatment
acetaminophen ...Study Participants
35Acetaminophen 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.
4 g/day for 10 consecutive days
all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
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
| Event Type | Organ System | Event Term | Acetaminophen |
|---|
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.
ALT was measured at Day 0, 4, 7, 9, 11, and 14.
