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Trial record 1 of 4 for:    ACETAMINOPHEN METABOLISM
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Effect on Acetaminophen Metabolism by Liquid Formulations

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ClinicalTrials.gov Identifier: NCT01246713
Recruitment Status : Completed
First Posted : November 23, 2010
Results First Posted : May 8, 2013
Last Update Posted : May 8, 2017
Sponsor:
Collaborators:
Harvard University
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Michael Ganetsky, Beth Israel Deaconess Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Acetaminophen Metabolism
Acetaminophen Poisoning
Drug Metabolism by Excipients
Interventions Drug: Acetaminophen liquid formulation
Drug: Acetaminophen solid formulation
Enrollment 15
Recruitment Details  
Pre-assignment Details Whether subjects received the solid or liquid preparation initially was randomly chosen.
Arm/Group Title Solid Acetaminophen First, Then Liquid Acetaminophen Liquid Acetaminophen First, Then Solid Acetaminophen
Hide Arm/Group Description Study participants randomized to receive solid formulation first. They received a 15mg/kg dose of a solid acetaminophen formulation for pharmacokinetic sampling on first study day, then had at least a 2 week washout period, then received a 15mg/kg dose of a liquid acetaminophen formulation for pharmacokinetic sampling on subsequent study day. Study participants randomized to receive liquid formulation first. They received a 15mg/kg dose of a liquid acetaminophen formulation for pharmacokinetic sampling on first study day, then had at least a 2 week washout period, then received a 15mg/kg dose of a solid acetaminophen formulation for pharmacokinetic sampling on subsequent study day.
Period Title: First Acetaminophen Dosing (1 Day)
Started 6 9
Completed 6 9
Not Completed 0 0
Period Title: Washout (at Least 14 Days)
Started 6 9
Completed 6 9
Not Completed 0 0
Period Title: Second Acetaminophen Dosing (1 Day)
Started 6 9
Completed 6 9
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description All study participants received a 15mg/kg dose of a solid acetaminophen formulation and a 15mg/kg dose of a liquid acetaminophen formulation separated by at least a 2 week washout period.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
5
  33.3%
Male
10
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Acetaminophen Metabolites
Hide Description 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.
Time Frame 8 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Solid Formulation Acetaminophen Liquid Formulation
Hide Arm/Group Description:
Subjects in this arm will receive a 15mg/kg dose of a solid acetaminophen formulation. Results for APAP-cysteinate metabolite
Subjects in this arm will receive a 15mg/kg dose of a liquid acetaminophen formulation. Results for APAP-cysteinate metabolite
Overall Number of Participants Analyzed 15 15
Mean (Standard Error)
Unit of Measure: mcg.hr/ml
2.411  (0.21) 2.009  (0.17)
Time Frame Adverse even data was collected during the study period (first day of dosing, at least 2 week washout period, second day of dosing)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Solid Acetaminophen First, Then Liquid Acetaminophen Liquid Acetaminophen First, Then Solid Acetaminophen
Hide Arm/Group Description Participants in arm Solid Acetaminophen First: received a single 15mg/kg dose of a solid acetaminophen formulation first, and then a 15mg/kg dose of a liquid acetaminophen formulation after a 2 week washout period. Participants in arm Liquid Acetaminophen First: received a single 15mg/kg dose of a liquid acetaminophen formulation, and then a 15mg/kg dose of a solid acetaminophen formulation after a 2 week washout period.
All-Cause Mortality
Solid Acetaminophen First, Then Liquid Acetaminophen Liquid Acetaminophen First, Then Solid Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Solid Acetaminophen First, Then Liquid Acetaminophen Liquid Acetaminophen First, Then Solid Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Solid Acetaminophen First, Then Liquid Acetaminophen Liquid Acetaminophen First, Then Solid Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/9 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Michael Ganetsky, MD
Organization: BIDMC
Phone: 6177542323
Responsible Party: Michael Ganetsky, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01246713     History of Changes
Other Study ID Numbers: 2010P000135
UL1RR025758 ( U.S. NIH Grant/Contract )
First Submitted: November 22, 2010
First Posted: November 23, 2010
Results First Submitted: February 18, 2013
Results First Posted: May 8, 2013
Last Update Posted: May 8, 2017