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Pharmacotoxicology of Trichloroethylene Metabolites

NCT01128270 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2014-05-07

Study results available
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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

Conditions

  • Healthy

Interventions

DRUG

Dichloroacetate environmental dose

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

DRUG

Chloral Hydrate environmental dose

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

DRUG

Dichloroacetate therapeutic dose

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

DRUG

Chloral Hydrate therapeutic dose

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Peter W. Stacpoole, PhD, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01128270 on ClinicalTrials.gov