Pharmacotoxicology of Trichloroethylene Metabolites:

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

University of Florida

ClinicalTrials.gov Identifier:

NCT00874276

First received: April 1, 2009

Last updated: September 26, 2012

Last verified: September 2012

History of Changes

Purpose

To establish the relationship between human MAAI haplotype and DCA and tyrosine metabolism. This aim test the postulates that MAAI haplotype determines, and thus can predict,1) dose-dependent DCA kinetics and biotransformation and 2) DCA's effects on tyrosine metabolism.

Condition	Intervention
Healthy	Drug: Dichloroacetate 2.5.ug/kg Drug: DCA 25mg/kg Clinical Dose

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Pharmacotoxicology of Trichloroethylene Metabolites

Further study details as provided by University of Florida:

Primary Outcome Measures:

Hypothesize that subject's genotype will determine how DCA is metabolized [ Time Frame: August, 2009 - November 2012 ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	August 2009
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: DCA 2.5.ug/kg Dichloroacetate 2.5ug/kg /day is administered for five days.	Drug: Dichloroacetate 2.5.ug/kg Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2,3,4 subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged. Other Names: genotype DCA
Experimental: 'DCA 25mg/kg Clinical Dose' 25mg/kg of dichloroacetate (DCA) was given 30 days after low dose DCA. Clinical dose was given for five days.	Drug: DCA 25mg/kg Clinical Dose Subjects are admitted to the clinical research center Thirty days after the 2.5ug/kg dose. Subjects receive 25mg/kg/ day of DCA. On day 1 pharmacokinetics are done for 24hours. Days 2,3,4 subjects receive a dose of DCA. On day 5 subjects receive a dose of DCA and have pharmacokinetics for 24 hours and are then discharged home. Other Names: Dichloracetate Genotype pharmacokinetics

Arms

Assigned Interventions

Experimental: DCA 2.5.ug/kg

Dichloroacetate 2.5ug/kg /day is administered for five days.

Drug: Dichloroacetate 2.5.ug/kg

Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2,3,4 subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged.

Other Names:

genotype
DCA

Experimental: 'DCA 25mg/kg Clinical Dose'

25mg/kg of dichloroacetate (DCA) was given 30 days after low dose DCA. Clinical dose was given for five days.

Drug: DCA 25mg/kg Clinical Dose

Subjects are admitted to the clinical research center Thirty days after the 2.5ug/kg dose. Subjects receive 25mg/kg/ day of DCA. On day 1 pharmacokinetics are done for 24hours. Days 2,3,4 subjects receive a dose of DCA. On day 5 subjects receive a dose of DCA and have pharmacokinetics for 24 hours and are then discharged home.

Other Names:

Dichloracetate
Genotype
pharmacokinetics

Detailed Description:

The arms of the study involves an admission to the clinical research center. There participants will first take a low dose of DCA 2.5ug/kg for 5 days then wait 30 days and take a therapeutic dose of DCA 25mg/kg for 5 days On the first day and on the 5th day of taking DCA kinetics will be done. A total of 16 blood samples will be obtained through an intravenous catheter. Subjects will also breath into a test tube for the collection of CO2. Urine collection will also occur

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

Locations

United States, Florida
University of Florida Shands Hospital
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
ClinicalTrials.gov Identifier:	NCT00874276 History of Changes
Obsolete Identifiers:	NCT00874705
Other Study ID Numbers:	14617-CP-004
Study First Received:	April 1, 2009
Last Updated:	September 26, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Florida:

Chloral Hydrate
Dichloroacetate
Trichloroacetate

Additional relevant MeSH terms:

Trichloroethylene
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013

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