CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Dichloroacetate environmental dose +3 moredrug
Likely dose
Dichloroacetate therapeutic dose 25 mg/kgfrom record
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Search/NCT01128270
NCT01128270Phase 2Completed

Pharmacotoxicology of Trichloroethylene Metabolites Aim 3

University of Florida·interventional·Posted May 21, 2010·Updated May 7, 2014

In Brief

A Phase 2 clinical trial evaluating Dichloroacetate environmental dose, Chloral Hydrate environmental dose, and 2 other interventions for Healthy. Completed, enrolled 27 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 21, 2010
Enrollment StartApr 1, 2010
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.1 years ago

Interventions

Dichloroacetate environmental dosedrug

On day 6 they receive Dichloroacetate 2.5 ug/kg orally times 1 and have pharmacokinetics.

Chloral Hydrate environmental dosedrug

Study subjects are given 1.5 ug/kg of Chloral Hydrate for 5 nights and pharmacokinetics are done on night 1 and 5.

Dichloroacetate therapeutic dosedrug

Subjects receive 25 mg/kg DCA on Day 6. Pharmacokinetics are done on nights 1 and nights 5.

Chloral Hydrate therapeutic dosedrug

Subject is given 25 mg/kg of Chloral Hydrate for five nights.