NCT Number: NCT01021410
Acetaminophen-Protein Adduct Resolution
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
University of Colorado Hospital CTRC, Aurora, Colorado, United States
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Any subject randomized to the acetaminophen arm of COMIRB 06-1265 and meets completion criteria
Exclusion criteria
- Subjects who enter the extended dosing period in protocol 06-1265.
- Subjects who were randomized to placebo.
Treatment and study plan
Primary outcomes
-
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.
Time frame: Day 6
Secondary outcomes
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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.
Time frame: Days 3, 6, 9
Sponsors and collaborators
Lead sponsor
Denver Health and Hospital Authority
Other
Collaborators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Registry information
Official study title
Serum Acetaminophen-Cysteine (APAP-cys) Adduct Concentrations After 16 Days of Acetaminophen Dosing
Acronym: AR
Important dates
- Study start
- 2009
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Nov 30, 2009
- Registry last updated
- Aug 8, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.