Acetaminophen-Protein Adduct Resolution (AR)

Serum Acetaminophen-Cysteine (APAP-cys) Adduct Concentrations After 16 Days of Acetaminophen Dosing

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.

Study Overview

• Status: Completed
• Conditions: Acetaminophen-protein Adduct Formation

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital CTRC
    • Denver, Colorado, United States, 80204
      • Denver Health and Hospital Authority

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Denver Health and Hospital Authority
• Collaborators: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
• Investigators: Principal Investigator: Kennon Heard, MD, Denver Health and Hospital Authority

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: November 25, 2009
• First Submitted That Met QC Criteria: November 27, 2009
• First Posted (ESTIMATE): November 30, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): August 8, 2012
• Last Update Submitted That Met QC Criteria: August 7, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: healthy volunteer; acetaminophen; paracetamol; protein adduct; acetaminophen-protein adduct formation
• Other Study ID Numbers: COMIRB 09-0510