Phase 2
N=7
Pharmacotoxicology of Trichloroethylene Metabolites
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01128270 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Plasma DCA (Microgram/ml) After 5 Days of Therapeutic Level Chloral Hydrate on Arm 2A. — 1.64 micrograms/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dichloroacetate environmental dose (Drug); Chloral Hydrate environmental dose (Drug); Dichloroacetate therapeutic dose (Drug); Chloral Hydrate therapeutic dose (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma DCA (Microgram/ml) After 5 Days of Therapeutic Level Chloral Hydrate on Arm 2A. |
1.64 | — |
| PRIMARY Difference in Half Lives 5 Day Less One Day Exposure in Trichloroacetate |
2432 | 0.0017 sig |
| PRIMARY Urinary Maleylacetone Levels After 5 Day Exposure to Therapeutic Chloral Hydrate (Arm 2B) |
0.38 | — |
| SECONDARY Detectable DCA After Day 1 in Serum (0=No 1=Yes) |
0; 0; 0; 0 | — |
Summary
This is a research study to look at how Dichloroacetate (DCA), and investigational drug and chloral hydrate are broken down in the body. The purpose of the study is to better understand how humans metabolize these two common chemicals that are widely present in the environment. The study focuses on how the drug chloral hydrate is broken down and how it effects DCA
Eligibility Criteria
Inclusion Criteria
- healthy
- normal screening labs
Exclusion Criteria
- no gastrointestinal surgery
- no smoking
- no medication
- not pregnant
Data sourced from ClinicalTrials.gov (NCT01128270). 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.