Acetaminophen-protein Adduct Formation
Conditions
Keywords
acetaminophen, paracetamol, protein adduct, healthy volunteer, acetaminophen-protein adduct formation
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.
Interventions
None listed
Sponsors
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Denver Health and Hospital Authority
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed