Clinical Trial: Pharmacotoxicology of Trichloroethylene Metabolites

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Pharmacotoxicology of Trichloroethylene Metabolites

Brief Summary: To establish the relationship between human MAAI haplotype and DCA and tyrosine metabolism. This aim test the postulates that MAAI haplotype determines, and thus can predict,1) dose-dependent DCA kinetics and biotransformation.

Detailed Summary:

The arms of the study involves determining the haplotype of individuals enrolled. Then participants were divided into two groups based on their genotype. The groups include a genotype with an EGT alle and a group of genotype without an EGT alle. All subjects first took a low dose of DCA 2.5ug/kg for 5 days then wait 30 days and take a therapeutic dose of DCA 25mg/kg for 5 days On the first day and on the 5th day of taking DCA kinetics were be done. A total of 16 blood samples were obtained through an intravenous catheter. Urine collection will also occur.

Population pharmacogenetic analysis of MAI allelic frequencies and the GC or LC-MS/MS techniques for blood or urinary metabolites were used in this investigation. Pharmacokinetic data was used to determine metabolism rate of DCA for each allele


Sponsor: University of Florida

Current Primary Outcome: Hypothesize That Subject's Genotype Will Determine How DCA is Metabolized. [ Time Frame: 24 hours for analysis on Day 5, Clinical dose ]

Terminal half-life (the amount of time needed to clear one-half of dose of the drug).


Original Primary Outcome: Hypothesize that the log half-life of CH or DCA will increase ≥ 2-fold from day 1 - day 5 for each treatment. [ Time Frame: August, 2009 - February, 2011 ]

Current Secondary Outcome: Terminal Half-life (the Amount of Time Needed to Clear One-half of the Dose of Drug)for Environmental Dose 2.5 ug/kg/Day. [ Time Frame: 24 hours for analysis on Day 5, Environmental dose ]

Terminal half-life (the amount of time needed to clear one-half of the dose of drug)for the environmental dose 2.5 ug/kg/day.


Original Secondary Outcome:

Information By: University of Florida

Dates:
Date Received: April 1, 2009
Date Started: August 2009
Date Completion:
Last Updated: June 3, 2015
Last Verified: March 2013