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Trial record 1 of 1 for:    12723459 [PUBMED-IDS]
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Pharmacotoxicology of Trichloroethylene Metabolites

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ClinicalTrials.gov Identifier: NCT00865514
Recruitment Status : Terminated (Difficulty in obtaining the solution from the compounding pharmacies caused a two year delay in start-up; the funding ended prior to study completion.)
First Posted : March 19, 2009
Results First Posted : June 20, 2013
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Healthy
Interventions: Drug: Dichloroacetate
Genetic: Genotyping
Other: Leucine
Other: tyrosine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The participants were recruited by a posted advertisement.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two subjects were enrolled but did not participate in the study. One subject was delayed because the solution for the infusion had particles in it and then didn't continue(didn't receive any intervention) due to funding issues, and the second one was enrolled but didn't receive any intervention due to funding issues that have been explained.

Reporting Groups
  Description
Haplotypes and DCA Metabolism Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.

Participant Flow:   Overall Study
    Haplotypes and DCA Metabolism
STARTED   2 
COMPLETED   0 
NOT COMPLETED   2 
Infusion cost exceeded funding                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Haplotypes and DCA Metabolism Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.

Baseline Measures
   Haplotypes and DCA Metabolism 
Overall Participants Analyzed 
[Units: Participants]
 2 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   2 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   1 
Male   1 
Region of Enrollment 
[Units: Participants]
 
United States   2 


  Outcome Measures

1.  Primary:   The Interaction of DCA and/or Tyrosine Breakdown Products and Maleylacetoacetate Isomerase (MAAI) in Vivo.   [ Time Frame: One week ]

2.  Secondary:   Inhibition of Tyrosine and Individual's Haplotype   [ Time Frame: one week ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Peter W. Stacpoole
Organization: University of Florida
phone: (352) 273-9023
e-mail: pws@ufl.edu


Publications:
LARC Monogr Eval Carcinog Risks Hum 11:263-276,1979.
Page N. Assessment of trichloroethylene as an occupational carcinogen. In: Davis W, Rosenfeld C, eds. Carcinogenic risks: strategies for intervention INSERM Symposia series Vol. 74. Lyon, France: International Agency for Reserach on Cancerl; IARC Scientific Publications E No. 25, 1979.
Federal Register 40(203):49032-49045, 1975.
Westrick JJ, Mello JW, Thomas RF. The groundwater supply survey. J Am Water Works 76:52, 1984.
Uden PCC, Miller JW. Chlorinated acids and chloral in drinking water. J Amer Water Works Assoc 75:524-527, 1983.
Jolley RL. Basic issues in water chlorination: a chemical perspective. In, Water chlorination: chemistry, environmental impact and health effects. Lewis Publ, Inc. Chelsea, MI 5:19-38, 1985.
Salmon AG, Jackson RJ, Smith MT. Chloral hydrate: cancer risk assessment of a drug previously presumed safe. The Toxicologist 11:350, 1991.
Liebreich O. Das Chloral hydrat, ein neues Hypnoticum und Anaestheticum, 3rd ed. Berlin: Otto Mullers Verlag, 1869.
Toxicological review of dichloroacetic acid (CAS No. 79-43-6). U.S. Environ. Protection Agency. Washington, DC, August, 2003.
Gonzalez-Leon A, Schultz IR, Bull RJ. Species differences in the toxicokinetics of dichloroacetate and trichloroacetate in F344 rats and B6C3F1 mice after prolonged administration in drinking water. Fundam Appl Toxicol Suppl 36, Abst. 168, p. 33, 1997.
NTP Technical Report. Toxicology and carcinogenesis study of chloral hydrate. NIH Publication No. 03-4437, 2002.
IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Chloral hydrate. World Health Organization, 2004, pp. 317-358.
Kinter M, Sherman NE. Peptide Sequencng andIdentifcation Using Tandem Mass Specrometry. John Wiley and Sons, Inc., pp. 147-165, 2000.
Proteome Research: mass spectrometry. Peter James. Springer, pp. 5-9 2001.


Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00865514     History of Changes
Other Study ID Numbers: 14617-CP-001
5R01ES014617 ( U.S. NIH Grant/Contract )
First Submitted: March 17, 2009
First Posted: March 19, 2009
Results First Submitted: March 21, 2013
Results First Posted: June 20, 2013
Last Update Posted: June 3, 2015