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Completed

NCT Number: NCT00616018

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

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.

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Key information

Conditions

Drug Induced Liver Injury Chemical and Drug Induced Liver Injury Chemically-Induced Disorders Digestive System Diseases Drug-Related Side Effects and Adverse Reactions Liver Diseases Poisoning

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Denver Health Rocky Mountain Poison and Drug Center

Denver, Colorado, 80204, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen

Drug

4 g/day for 10 consecutive days

Other names: Tylenol Extra Strength

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kennon Heard

Other

Collaborators

  • McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Registry information

Official study title

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

Acronym: Non-Drinker

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 14, 2008
Registry last updated
Jul 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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