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NCT Number: NCT01128270

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

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Key information

Conditions

Healthy

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy
  • normal screening labs

Exclusion criteria

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

Treatment and study plan

Dichloroacetate environmental dose

Drug

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

Other names: DCA

Chloral Hydrate environmental dose

Drug

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

Dichloroacetate therapeutic dose

Drug

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

Other names: DCA

Chloral Hydrate therapeutic dose

Drug

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

Primary outcomes

  1. Plasma DCA (Microgram/ml) After 5 Days of Therapeutic Level Chloral Hydrate on Arm 2A.

    Time frame: 6 Days

    After 5 days of of therapeutic level Chloral Hydrate, the levels of Dichloroacetate in the plasma were measured.

  2. Difference in Half Lives 5 Day Less One Day Exposure in Trichloroacetate

    Time frame: 5 days

    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.

  3. Urinary Maleylacetone Levels After 5 Day Exposure to Therapeutic Chloral Hydrate (Arm 2B)

    Time frame: 5 days

    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.

Secondary outcomes

  1. Detectable DCA After Day 1 in Serum (0=No 1=Yes)

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Pharmacotoxicology of Trichloroethylene Metabolites Aim 3

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 21, 2010
Registry last updated
May 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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