CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Dichloroacetate (DCA) +1 moredrug
Likely dose
Dichloroacetate (DCA) 25mg/kgfrom record
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Search/NCT00874276
NCT00874276N/ACompleted
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Pharmacotoxicology of Trichloroethylene Metabolites

University of Florida·interventional·Posted Apr 2, 2009·Updated Jun 4, 2015

In Brief

A clinical study evaluating Dichloroacetate (DCA) and Genetic Marker on Chromosome 14q24.3 for Congenital Lactic Acidosis. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Lactic Acidosis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2, 2009
Enrollment StartAug 1, 2009
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.3 years ago

Interventions

Dichloroacetate (DCA)drug

Dichloroacetate 2.5.ug/kg will be administered for five days in the clinical research center. On day 5 with the dose of DCA a pharmacokinetics test will be performed for 24 hours. 30 days later the individuals will return to the clinic and receive Dichloroacetate 25mg/kg (clinical dose) for five days. On day 1 and day 5 Pharmacokinetics will be performed to determine the relationship between DCA metabolism and haplotype.

Genetic Marker on Chromosome 14q24.3genetic

Individuals were genotyped at the beginning of the study and their haplotypes were defined. The study is looking at individuals with genetic markers on Chromosome 14q24.3 to determine if there will be a difference in how the DCA will be metabolized.