Acetaminophen-Protein Adduct Resolution

Completed

Conditions studied: Acetaminophen-protein Adduct Formation

In brief

The purpose of this study is to better understand the pharmacokinetics of acetaminophen and further clinical interpretations of laboratory results that confirm the presence of acetaminophen-cys adducts. This study will determine how long adducts persist in serum after a therapeutic course of acetaminophen as taken in a previous study (COMIRB 06-1265). Subjects will be asked to complete three study visits, each three days apart, following termination of COMIRB 06-1265. Each study visit will include collection of blood samples for batch testing of aminotransferase, serum acetaminophen and protein adducts. No interventions are planned.

Key facts

Study ID

NCT01021410

Run by

Denver Health and Hospital Authority

People needed

100

Starts

2009-11-01

Expected to finish

2011-03-01

Last updated by the study team

2012-08-08

Who can join

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

You may qualify if…

• Any subject randomized to the acetaminophen arm of COMIRB 06-1265 and meets completion criteria

You may not qualify if…

• Subjects who enter the extended dosing period in protocol 06-1265.
• Subjects who were randomized to placebo.

Where it is running

• University of Colorado Hospital CTRC — Aurora, Colorado, United States
• Denver Health and Hospital Authority — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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