Acetaminophen-Protein Adduct Resolution (AR)
This study has been completed.
Sponsor:
Denver Health and Hospital Authority
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by (Responsible Party):
Kennon Heard, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT01021410
First received: November 25, 2009
Last updated: August 7, 2012
Last verified: August 2012
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Purpose
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.
| Condition |
|---|
|
Acetaminophen-protein Adduct Formation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Serum Acetaminophen-Cysteine (APAP-cys) Adduct Concentrations After 16 Days of Acetaminophen Dosing |
Resource links provided by NLM:
Further study details as provided by Denver Health and Hospital Authority:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
serum
| Enrollment: | 100 |
| Study Start Date: | November 2009 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Acetaminophen Group
Subjects who completed COMIRB 06-1265 and were assigned to the acetaminophen treatment group for that study.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
All subjects who have met completion criteria for COMIRB 06-1265 and were assigned to the acetaminophen treatment group for that study.
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021410
Locations
| United States, Colorado | |
| University of Colorado Hospital CTRC | |
| Aurora, Colorado, United States, 80045 | |
| Denver Health and Hospital Authority | |
| Denver, Colorado, United States, 80204 | |
Sponsors and Collaborators
Denver Health and Hospital Authority
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Investigators
| Principal Investigator: | Kennon Heard, MD | Denver Health and Hospital Authority |
More Information
No publications provided
| Responsible Party: | Kennon Heard, Fellowship Director, Denver Health and Hospital Authority |
| ClinicalTrials.gov Identifier: | NCT01021410 History of Changes |
| Other Study ID Numbers: | COMIRB 09-0510 |
| Study First Received: | November 25, 2009 |
| Last Updated: | August 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Denver Health and Hospital Authority:
|
acetaminophen paracetamol protein adduct healthy volunteer acetaminophen-protein adduct formation |
Additional relevant MeSH terms:
|
Acetaminophen Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013