Acetaminophen-Protein Adduct Resolution
- Conditions
- Acetaminophen-protein Adduct Formation
- Registration Number
- NCT01021410
- Lead Sponsor
- Denver Health and Hospital Authority
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Any subject randomized to the acetaminophen arm of COMIRB 06-1265 and meets completion criteria
- Subjects who enter the extended dosing period in protocol 06-1265.
- Subjects who were randomized to placebo.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of the proposed study is to determine the proportion of subjects with acetaminophen-cys adduct concentrations above the limit of quantification at day 6 after stopping maximum acetaminophen dosing. Day 6
- Secondary Outcome Measures
Name Time Method The secondary outcomes of the proposed study are the serum acetaminophen-cys adduct concentrations at 3, 6, 9 days after stopping maximum acetaminophen dosing of the COMIRB 06-1265 study. Days 3, 6, 9
Trial Locations
- Locations (2)
University of Colorado Hospital CTRC
🇺🇸Aurora, Colorado, United States
Denver Health and Hospital Authority
🇺🇸Denver, Colorado, United States