Pharmacotoxicology of Trichloroethylene Metabolites

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01128270
First received: May 20, 2010
Last updated: March 11, 2013
Last verified: March 2013

May 20, 2010
March 11, 2013
April 2010
October 2012   (final data collection date for primary outcome measure)
Determine the in vivo kinetics and biotransformation of chloral hydrate [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01128270 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Pharmacotoxicology of Trichloroethylene Metabolites
Pharmacotoxicology of Trichloroethylene Metabolites Aim 3

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

The subject's general health is assessed by a history and physical exam and routine blood work. I normal the individual undergoes five nights of receiving 1.5ug/kg of chloral hydrate. On day 6 the individual receives 2.5mg/kg of Dichloroacetate (DCA)and kinetics are drawn. After 30 days the subject comes back and receives 1.5ug/kg of chloral hydrate for five nights and has kinetics drawn on night one and five. On days 6-9 the subject returns for a blood draw. After 30 days the same process as above is done except the subject receives 1gram of chloral hydrate for five nights and 25mg/kg of Dichloroacetate one day then 30 days later the subject receives 1gram of chloral hydrate for five nights and has kinetics done on night one and five and blood samples drawn on days 6-9

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • Drug: Chloral Hydrate and Dichloroacetate
    Subjects are given 1.5mcg/kg of chloral hydrate for 5 nights, On day 6 they receive Dichloroacetate 2.5 mcg/kg orally times 1 and have pharmacokinetics.
    Other Names:
    • Metabolism
    • Kinetics
    • Genotype
  • Drug: Chloral Hydrate
    For the second arm of the study subjects are given 1.5mcg/kg of chloral hydrate for 5 nights and pharmacokinetics are done on night 1 and 5.
    Other Name: pharmacokinetics
  • Drug: chloral hydrate therapeutic dose
    The next arm 30 days apart the subjects receive 1 gram of chloral hydrate for 5 nights and kinetics are done on nights 1 and nights 5.
    Other Names:
    • DCA
    • pharmacokinetics
  • Drug: Chloral Hydrate and DCA therapeutic
    30 days later the subject is given 1 gram of chloral hydrate for five nights and on day 6 25mg/kg. of dichloroacetate and pharmacokinetics are done.
    Other Names:
    • DCA
    • pharmacokentics
    • sedative
  • Experimental: Chloral Hydrate and Dichloroacetate
    Subjects consume chloral hydrate 1.5ug/kg by mouth for 5 nights. On the 6th day they consume DCA 2.5ug/kg by mouth and have blood samples drawn
    Intervention: Drug: Chloral Hydrate and Dichloroacetate
  • Experimental: Chloral Hydrate therapeutic dose
    Drug Study Subjects are admitted to the clinical research unit and receive 1 gram (therapeutic dose) of chloral hydrate for 5 nights. Pharmacokinetics are done on days 1 and day 5.
    Intervention: Drug: chloral hydrate therapeutic dose
  • Experimental: Chloral Hydrate and DCA therapeutic
    Drug Study Subjects are admitted to the clinical research center and receive a clinical dose of chloral hydrate for 5 nights. On day 6 they are given a clinical dose (25mg/kg)of Dichloroacetate
    Intervention: Drug: Chloral Hydrate and DCA therapeutic
  • Experimental: Chloral Hydrate
    Subjects are given 1.5mcg of Chloral Hydrae for five nights and pharmacokinetics are done on days 1 and 5.
    Intervention: Drug: Chloral Hydrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy
  • normal screening labs

Exclusion Criteria:

  • no gastrointestinal surgery
  • no smoking
  • no medication
  • not pregnant
Both
21 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01128270
IRB#107-10, RO1ESO141617
No
University of Florida
University of Florida
National Institutes of Health (NIH)
Principal Investigator: Peter W. Stacpoole, PhD, MD University of Florida
University of Florida
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP