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Sponsors and Collaborators: |
Denver Health and Hospital Authority McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
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Information provided by: | Denver Health and Hospital Authority |
ClinicalTrials.gov Identifier: | NCT00616018 |
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 | Intervention | Phase |
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Drug Induced Liver Injury |
Drug: acetaminophen |
Phase IV |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Acetaminophen Adduct Formation in Alcohol Abstaining Subjects Administered Therapeutic Doses of Acetaminophen for Ten Consecutive Days |
Enrollment: | 35 |
Study Start Date: | August 2007 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
all subjects receive acetaminophen in this open-label study
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Drug: acetaminophen
4 g/day for 10 consecutive days
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Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Colorado | |
Denver Health Rocky Mountain Poison and Drug Center | |
Denver, Colorado, United States, 80204 |
Principal Investigator: | Kennon Heard, MD | Denver Health/Rocky Mountain Poison & Drug Center |
Responsible Party: | Denver Health/Rocky Mountain Poison and Drug Center ( Kennon Heard, MD/Medical Toxicology Fellowship Director ) |
Study ID Numbers: | COMIRB #06-1187, COMIRB #06-1187 |
Study First Received: | February 4, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00616018 History of Changes |
Health Authority: | United States: Food and Drug Administration |
acetaminophen protein adducts hepatic function drug safety non drinkers |
Analgesics, Non-Narcotic Peripheral Nervous System Agents Analgesics Acetaminophen Ethanol |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs Peripheral Nervous System Agents |
Analgesics Central Nervous System Agents Pharmacologic Actions Acetaminophen |