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Acetaminophen-Protein Adduct Resolution (AR)

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ClinicalTrials.gov Identifier: NCT01021410
Recruitment Status : Completed
First Posted : November 30, 2009
Last Update Posted : August 8, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Acetaminophen-protein Adduct Formation

Study Design

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serum Acetaminophen-Cysteine (APAP-cys) Adduct Concentrations After 16 Days of Acetaminophen Dosing
Study Start Date : November 2009
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Acetaminophen Group
Subjects who completed COMIRB 06-1265 and were assigned to the acetaminophen treatment group for that study.

Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples Without DNA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021410

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.
Principal Investigator: Kennon Heard, MD Denver Health and Hospital Authority
More Information

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
First Posted: November 30, 2009    Key Record Dates
Last Update Posted: August 8, 2012
Last Verified: August 2012

Keywords provided by Kennon Heard, Denver Health and Hospital Authority:
protein adduct
healthy volunteer
acetaminophen-protein adduct formation

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs