Pharmacotoxicology of Trichloroethylene Metabolites

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

• 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

Inclusion Criteria:

• healthy
• normal screening labs

Exclusion Criteria:

• no gastrointestinal surgery
• no smoking
• no medication
• not pregnant