Effect on Acetaminophen Metabolism by Liquid Formulations
2 other identifiers
interventional
15
1 country
1
Brief Summary
The purpose of this study is to determine whether excipients in the liquid formulation of acetaminophen prevent the formation of the toxic metabolites of acetaminophen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2010
CompletedFirst Posted
Study publicly available on registry
November 23, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
May 8, 2013
CompletedMay 8, 2017
March 1, 2017
5 months
November 22, 2010
February 18, 2013
March 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acetaminophen Metabolites
Area-under-curve from time zero to 8 hours for APAP-cysteinate metabolite. Serum was collected just prior to and at hours 1, 2, 4, 6, and 8 after administration of the APAP dose.
8 hours
Study Arms (2)
Acetaminophen solid formulation
PLACEBO COMPARATORSubjects in this arm will receive a 15mg/kg dose of a solid acetaminophen formulation.
Acetaminophen liquid formulation
ACTIVE COMPARATORSubjects in this arm will receive a 15mg/kg dose of a liquid acetaminophen formulation.
Interventions
Subjects in this arm will receive a 15mg/kg dose of a solid acetaminophen formulation.
Subjects in this arm will receive a 15mg/kg dose of a solid acetaminophen formulation.
Eligibility Criteria
You may qualify if:
- Healthy volunteer ages 18-40
- Not taking any chronic medications
You may not qualify if:
- Pregnancy
- Any history of liver disease
- Frequent alcohol use (2 or more drinks more than 4 times per week)
- Unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beth Israel Deaconess Medical Centerlead
- Harvard Universitycollaborator
- National Center for Research Resources (NCRR)collaborator
Study Sites (1)
Harvard - Thorndike Clinical Research Center at Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (1)
Ganetsky M, Bohlke M, Pereira L, Williams D, LeDuc B, Guatam S, Salhanick SD. Effect of excipients on acetaminophen metabolism and its implications for prevention of liver injury. J Clin Pharmacol. 2013 Apr;53(4):413-20. doi: 10.1002/jcph.24. Epub 2013 Feb 22.
PMID: 23436315DERIVED
Results Point of Contact
- Title
- Michael Ganetsky, MD
- Organization
- BIDMC
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Ganetsky, MD
Beth Israel Deaconess Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Emergency Medicine
Study Record Dates
First Submitted
November 22, 2010
First Posted
November 23, 2010
Study Start
December 1, 2010
Primary Completion
May 1, 2011
Study Completion
July 1, 2012
Last Updated
May 8, 2017
Results First Posted
May 8, 2013
Record last verified: 2017-03