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Pharmacotoxicology of Trichloroethylene Metabolites

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
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
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Chloral Hydrate and Dichloroacetate
Drug: Chloral Hydrate
Drug: chloral hydrate therapeutic dose
Drug: Chloral Hydrate and DCA therapeutic
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Pharmacotoxicology of Trichloroethylene Metabolites Aim 3

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Determine the in vivo kinetics and biotransformation of chloral hydrate [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: April 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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
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.
 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
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
 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
Subjects are given 1.5mcg of Chloral Hydrae for five nights and pharmacokinetics are done on days 1 and 5.
 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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy
  • normal screening labs

Exclusion Criteria:

  • no gastrointestinal surgery
  • no smoking
  • no medication
  • not pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128270

Locations
United States, Florida
University of Florida College of Medicine
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
National Institutes of Health (NIH)
Investigators
Principal Investigator: Peter W. Stacpoole, PhD, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01128270     History of Changes
Other Study ID Numbers: IRB#107-10, RO1ESO141617
Study First Received: May 20, 2010
Last Updated: March 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Florida:
Dichloroacetate
Chloral Hydrate
Metabolism

Additional relevant MeSH terms:
Chloral Hydrate
Trichloroethylene
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on May 19, 2013