| February 4, 2008 |
| February 6, 2009 |
| August 2007 |
| January 2008 (final data collection date for primary outcome measure) |
| serum level of APAP-Cys protein adducts [ Time Frame: before, during and following 10 days of therapy ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00616018 on ClinicalTrials.gov Archive Site |
| alanine aminotransferase (ALT) [ Time Frame: before, during and following 10 days of therapy ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days |
| 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. |
| |
| Phase IV |
| Interventional |
| Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Drug Induced Liver Injury |
| Drug: acetaminophen |
| Experimental: all subjects receive acetaminophen in this open-label study |
| |
| |
| Completed |
| 35 |
| January 2008 |
| January 2008 (final data collection date for primary outcome measure) |
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 four days preceding study enrollment
- Currently taking isoniazid
- Consumption of any alcoholic beverage during the run-in period
- A detectable serum acetaminophen at baseline
- Serum ALT or 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
|
| Both |
| 21 Years and older |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00616018 |
| Kennon Heard, MD/Medical Toxicology Fellowship Director, Denver Health/Rocky Mountain Poison and Drug Center |
| COMIRB #06-1187, COMIRB #06-1187 |
| Denver Health and Hospital Authority |
| McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
| Principal Investigator: |
Kennon Heard, MD |
Denver Health/Rocky Mountain Poison & Drug Center |
|
|
| Denver Health and Hospital Authority |
| February 2009 |