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

NCT ID: NCT00616018

Last Updated: 2012-07-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Drug Induced Liver Injury

Keywords

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acetaminophen protein adducts hepatic function drug safety non drinkers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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A

all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study

Group Type EXPERIMENTAL

acetaminophen

Intervention Type DRUG

4 g/day for 10 consecutive days

Interventions

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acetaminophen

4 g/day for 10 consecutive days

Intervention Type DRUG

Other Intervention Names

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Tylenol Extra Strength

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

INDUSTRY

Sponsor Role collaborator

Kennon Heard

OTHER

Sponsor Role lead

Responsible Party

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Kennon Heard

Medical Toxicology Fellowship Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kennon Heard, MD

Role: PRINCIPAL_INVESTIGATOR

Denver Health/Rocky Mountain Poison & Drug Center

Locations

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Denver Health Rocky Mountain Poison and Drug Center

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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COMIRB #06-1187

Identifier Type: -

Identifier Source: secondary_id

COMIRB #06-1187

Identifier Type: -

Identifier Source: org_study_id