Pharmacotoxicology of Trichloroethylene Metabolites: In Vivo Kinetics and Biotransformation of Chloral Hydrate - Full Text View

Sponsored by:	University of Florida
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00874276

Purpose

Specific Aim 3: Determine the in vivo kinetics and biotransformation of CH in healthy adults and the influence of CH and DCA on each other's metabolism. This specific aim will examine three postulates: 1) CH is metabolized in adults to DCA, 2) CH, via DCA formation, inhibits its own metabolism and that of tyrosine and 3) these effects are dependent upon exposure level but not upon gender. Both 13C and 12C CH and 13C DCA will be administered by mouth at environmentally relevant (μg/kg) and clinically relevant (mg/kg) doses to adult men and women and the kinetics and metabolism of these chemicals will be identified and quantitated using GC-MS and LC-MS.

Condition	Intervention
Healthy Volunteers	Drug: Chloral Hydrate

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Pharmacotoxicology of Trichloroethylene Metabolites

Resource links provided by NLM:

Drug Information available for: Trichloroethylene Chloral hydrate

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:

Hypothesize that the log half-life of CH or DCA will increase ≥ 2-fold from day 1 - day 5 for each treatment. [ Time Frame: August, 2009 - February, 2011 ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	August 2009
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Intervention Details:

The dose will be 100% [13C] CH on days 1 in dose 1A and 2A. For subjects in dose 2 they will receive 100% 12C CH on days 1 through 5. On day 5 subjects in groups 1A, 2A and 2B will receive 100% 12C CH and groups 1B will receive 100% [13C] CH. This will allow us to distinguish the 13C-DCA administered from that generated from CH and thus, CH kinetics from that of 13C-DCA.

Eligibility

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

Criteria

Inclusion Criteria:

Healthy volunteers

Exclusion Criteria:

Pregnancy
Other medications
Psychiatric illness on meds
Abnormal labs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874276

Contacts

Contact: Peter W Stacpoole, PhD, MD	(352) 273-8700	pws@ufl.edu
Contact: Bonnie S Coats, ARNP	(352) 392-6196	bonnie.coats@medicine.ufl.edu

Locations

United States, Florida
University of Florida
Gainesville, Florida, United States, 32610

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator:

Peter W Stacpoole, PhD, MD

University of Florida

More Information

No publications provided

Responsible Party:	University of Florida ( Peter W. Stacpoole, PhD, MD )
Study ID Numbers:	14617-CP-004
Study First Received:	April 1, 2009
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00874276 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Florida:

Chloral Hydrate
Dichloroacetate
Trichloroacetate

Study placed in the following topic categories:

Anesthetics, Inhalation
Anesthetics, General
Hypnotics and Sedatives
Anesthetics

Central Nervous System Depressants
Trichloroethylene
Healthy
Chloral Hydrate

Additional relevant MeSH terms:

Anesthetics, Inhalation
Anesthetics, General
Therapeutic Uses
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics

Central Nervous System Depressants
Trichloroethylene
Central Nervous System Agents
Chloral Hydrate
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009