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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00616018
Recruitment Status : Completed
First Posted : February 14, 2008
Results First Posted : July 12, 2012
Last Update Posted : July 12, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Drug Induced Liver Injury Drug: acetaminophen Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Acetaminophen Adduct Formation in Alcohol Abstaining Subjects Administered Therapeutic Doses of Acetaminophen for Ten Consecutive Days
Study Start Date : August 2007
Primary Completion Date : January 2008
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
Drug: acetaminophen
4 g/day for 10 consecutive days
Other Name: Tylenol Extra Strength

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Eligibility Criteria

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 4 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 alanine aminotransferase (ALT) or aspartate aminotransferase (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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616018

United States, Colorado
Denver Health Rocky Mountain Poison and Drug Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Kennon Heard
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Principal Investigator: Kennon Heard, MD Denver Health/Rocky Mountain Poison & Drug Center
More Information

Responsible Party: Kennon Heard, Medical Toxicology Fellowship Director, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT00616018     History of Changes
Other Study ID Numbers: COMIRB #06-1187
First Posted: February 14, 2008    Key Record Dates
Results First Posted: July 12, 2012
Last Update Posted: July 12, 2012
Last Verified: July 2012

Keywords provided by Kennon Heard, Denver Health and Hospital Authority:
protein adducts
hepatic function
drug safety
non drinkers

Additional relevant MeSH terms:
Chemical and Drug Induced Liver Injury
Liver Diseases
Digestive System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs