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: April 8, 2014
Last verified: April 2014

May 20, 2010
April 8, 2014
April 2010
October 2012   (final data collection date for primary outcome measure)
  • Plasma DCA (Microgram/ml) After 5 Days of Therapeutic Level Chloral Hydrate on Arm 2A. [ Time Frame: 6 Days ] [ Designated as safety issue: No ]
    After 5 days of of therapeutic level Chloral Hydrate, the levels of Dichloroacetate in the plasma were measured.
  • Difference in Half Lives 5 Day Less One Day Exposure in Trichloroacetate [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Elimination Half-life Difference on Arm 2B for 13C-Labeled trichloroacetate between day 5 (prolonged exposure) and day 1 (de novo exposure) after therapeutic level exposure to Chloral Hydrate. This outcome only applies to Period 4. Trichloroacetate is a marker, not an intervention.
  • Urinary Maleylacetone Levels After 5 Day Exposure to Therapeutic Chloral Hydrate (Arm 2B) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    The levels were clinically indetectable at baseline and the question was whether or not substantive levels would be noted at after 5 days exposure to Chloral Hydrate. Detectable, but low levels were detected.
Determine the in vivo kinetics and biotransformation of chloral hydrate [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01128270 on ClinicalTrials.gov Archive Site
Detectable DCA After Day 1 in Serum (0=No 1=Yes) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
All four arms receive Chloral Hydrate on Day 1 (arms 1A and 1B environmental levels) and (arms 2A and 2B therapeutic levels). The question is could Dichloroacetate be detected in serum at the end of day 1. This analysis is purely descriptive, and no comparisons were planned.
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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 2.5 micrograms/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: Dichloroacetate environmental dose
    On day 6 they receive Dichloroacetate 2.5 ug/kg orally times 1 and have pharmacokinetics.
    Other Name: DCA
  • 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.
    Other Name: DCA
  • Drug: Chloral Hydrate therapeutic dose
    Subject is given 25 mg/kg of Chloral Hydrate for five nights.
  • Experimental: 1A: Chloral Hydrate and DCA: Env
    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. (Period 1)
    Interventions:
    • Drug: Dichloroacetate environmental dose
    • Drug: Chloral Hydrate environmental dose
  • Experimental: 1B: Chloral Hydrate Env dose
    Drug Study Subjects are admitted to the clinical research unit and receive 1.5 ug/kg (environmental dose) of Chloral Hydrate for 5 nights. Pharmacokinetics are done on days 1 and day 5. (Period 2)
    Intervention: Drug: Chloral Hydrate environmental dose
  • Experimental: 2A: 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 (25mg/kg). On day 6 they are given a clinical dose (25mg/kg)of Dichloroacetate. (Period 3)
    Interventions:
    • Drug: Dichloroacetate therapeutic dose
    • Drug: Chloral Hydrate therapeutic dose
  • Experimental: 2B: Chloral Hydrate Therapeutic
    Subjects are given 25 mg/kg of Chloral Hydrate for five nights. Pharmacokinetics are done on days 1 and 5. (Period 4)
    Intervention: Drug: Chloral Hydrate therapeutic dose
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
April 2014

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