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

July 10, 2012 updated by: Kennon Heard

Acetaminophen Adduct Formation in Alcohol Abstaining Subjects Administered 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health Rocky Mountain Poison and Drug Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Tylenol Extra Strength

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0, 4, 7, 9, 11, and 14.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0, 4, 7, 9, 11, and 14.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kennon Heard

Collaborators

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

Investigators

  • Principal Investigator: Kennon Heard, MD, Denver Health/Rocky Mountain Poison & Drug Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

February 4, 2008

First Submitted That Met QC Criteria

February 4, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

July 12, 2012

Last Update Submitted That Met QC Criteria

July 10, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMIRB #06-1187

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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