N/A
N=14
Pharmacotoxicology of Trichloroethylene Metabolites
Congenital Lactic Acidosis
Bottom Line
View on ClinicalTrials.gov: NCT00874276 ↗Enrolled (actual)
14
Serious AEs
7.1%
Results posted
Jun 2013
Primary outcome: Primary: Hypothesize That Subject's Genotype Will Determine How DCA is Metabolized. — 1592; 232 Minutes — p=0.023
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dichloroacetate (DCA) (Drug); Genetic Marker on Chromosome 14q24.3 (Genetic)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hypothesize That Subject's Genotype Will Determine How DCA is Metabolized. |
1592; 232 | 0.023 sig |
| SECONDARY 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. |
65.4; 74.3 | 0.42 |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy volunteers
Exclusion Criteria
- Pregnancy
- Other medications
- Psychiatric illness on meds
- Abnormal labs
Data sourced from ClinicalTrials.gov (NCT00874276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.