Pharmacotoxicology of Trichloroethylene Metabolites

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University of Florida

Status

Completed

Conditions

Congenital Lactic Acidosis

Treatments

Genetic: Genetic Marker on Chromosome 14q24.3
Drug: Dichloroacetate (DCA)

Study type

Interventional

Funder types

Other

Identifiers

NCT00874276
14617-CP-004

Details and patient eligibility

About

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.

Full description

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

Enrollment

21 patients

Sex

All

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy volunteers

Exclusion criteria

  • Pregnancy
  • Other medications
  • Psychiatric illness on meds
  • Abnormal labs

Trial design

21 participants in 2 patient groups

No EGT Allele, slow metabolizers for DCA
Experimental group
Description:
Individuals were genotyped at the beginning of the study and their haplotypes were defined. Dichloroacetate 2.5.ug/kg (non-clinical dose) 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.
Treatment:
Drug: Dichloroacetate (DCA)
Genetic: Genetic Marker on Chromosome 14q24.3
1+ EGT Allele, fast metabolizers for DCA
Experimental group
Description:
Individuals were genotyped at the beginning of the study and their haplotypes were defined. Dichloroacetate 2.5.ug/kg (non-clinical dose) 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.
Treatment:
Drug: Dichloroacetate (DCA)
Genetic: Genetic Marker on Chromosome 14q24.3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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