Aminotransferase Trends During Prolonged Acetaminophen Dosing

Completed · Phase 4 · Has a placebo group

Conditions studied: Drug Toxicity, Healthy

In brief

The objective of this study is to monitor liver function tests (blood levels of an indicator of liver function) of healthy people taking the maximum labeled daily dose of acetaminophen compared to people taking placebo for 16 to 40 days. Those people that continue to have normal liver tests after 16 days will have completed their part of the study. People that develop abnormal liver function tests will continue taking acetaminophen or placebo, and have their liver tests monitored closely for up to an additional 24 days. This is to (1) make sure these tests return to normal and (2) determine when these tests return to normal while still taking acetaminophen or placebo. If at any time the liver tests indicate anything more than a minor increase, you would be immediately told to stop taking the study drug. Secondary objective is to determine the proportion of subjects that have detectable acetaminophen-protein adducts after daily dosing.

Key facts

Study ID

NCT00743093

Run by

Denver Health and Hospital Authority

People needed

398

Starts

2008-08-01

Expected to finish

2011-08-01

Last updated by the study team

2013-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• age 18 or older

You may not qualify if…

• History of acetaminophen ingestion on any of the four days preceding study enrollment
• Measurable serum acetaminophen level at time of enrollment
• Viral markers of Hepatitis B or C, or viral markers of Hepatitis A with an ALT level greater than ULN during screening laboratory testing
• Serum ALT or AST level greater than ULN at Screening or Day 0
• Total bilirubin level greater than ULN at Screening or Day 0
• INR level greater than ULN at Screening
• Alkaline phosphatase level greater than ULN at Screening
• Platelet count less than 125 10\^9/L at Screening
• Known cholelithiasis
• Positive pregnancy test at Screening (female participants only)
• History of consuming more than an average of 3 alcohol containing drinks daily over the preceding 2 weeks
• History of consuming 3 or more alcohol containing drinks on any given day during the 2 weeks prior to study enrollment
• New prescription medication started within the previous 30 days
• Currently taking isoniazid
• Currently taking warfarin
• Currently adheres to a fasting type diet as determined by self report
• Currently has anorexia nervosa as determined by self report
• Participant is clinically intoxicated, psychiatrically impaired or unable to give informed consent for any reason
• Known hypersensitivity or allergy to acetaminophen

Where it is running

• University of Colorado Health Sciences Center - GCRC — Aurora, Colorado, United States
• Denver Health Rocky Mountain Poison and Drug Center — Denver, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.