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Acetaminophen-Protein Adduct Resolution

NCT ID: NCT01021410

Last Updated: 2012-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acetaminophen-protein Adduct Formation

Keywords

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acetaminophen paracetamol protein adduct healthy volunteer acetaminophen-protein adduct formation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acetaminophen Group

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

INDUSTRY

Sponsor Role collaborator

Denver Health and Hospital Authority

OTHER

Sponsor Role lead

Responsible Party

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Kennon Heard

Fellowship Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kennon Heard, MD

Role: PRINCIPAL_INVESTIGATOR

Denver Health and Hospital Authority

Locations

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University of Colorado Hospital CTRC

Aurora, Colorado, United States

Site Status

Denver Health and Hospital Authority

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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COMIRB 09-0510

Identifier Type: -

Identifier Source: org_study_id