Acetaminophen-Protein Adduct Resolution

NCT01021410 | Completed

• 1 other identifier: COMIRB 09-0510
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Acetaminophen-protein Adduct Formation

Keywords

acetaminophen; paracetamol; protein adduct; healthy volunteer; acetaminophen-protein adduct formation

Outcome Measures

Primary Outcomes (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.

  Day 6

Secondary Outcomes (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.

  Days 3, 6, 9

Study Arms (1)

Acetaminophen Group

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Any subject randomized to the acetaminophen arm of COMIRB 06-1265 and meets completion criteria

You may not qualify if:

• Subjects who enter the extended dosing period in protocol 06-1265.
• Subjects who were randomized to placebo.

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.: collaborator

Study Sites (2)

University of Colorado Hospital CTRC

Aurora, Colorado, 80045, United States

Location

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

Study Officials

• Kennon Heard, MD

  Denver Health and Hospital Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellowship Director

Study Record Dates

• First Submitted: November 25, 2009
• First Posted: November 30, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: August 8, 2012

Record last verified: 2012-08

Locations

US (2)