Status:

TERMINATED

Pharmacotoxicology of Trichloroethylene Metabolites

Lead Sponsor:

University of Florida

Conditions:

Healthy

Eligibility:

All Genders

22-60 years

Phase:

NA

Brief Summary

This project focuses on the kinetics, metabolism and human toxicology of dichloroacetate (DCA)and tyrosine catabolism. The hypothesis is that tyrosine metabolism will be greatest in subject who harbor...

Detailed Description

Specific Aim 4. Quantify the effects of DCA on human tyrosine metabolism and on its own biotransformation in relation to dose and genotype.

Eligibility Criteria

Inclusion

  • Adults scheduled for elective surgery for benign liver disease.
  • Normal EKG and history
  • Normal baseline labs

Exclusion

  • Pregnancy
  • severe anemia, defined as a hematocrit \< 30%.
  • diabetes mellitus
  • renal insufficiency, defined as a serum creatinine \> 1.5 mg/dl or a creatinine clearance \< 60 ml/min
  • elevated liver enzymes
  • psychiatric illness requiring medication
  • primary biliary cirrhosis or any other form of cirrhosis
  • viral hepatitis or non-viral steatohepatitis
  • coronary heart disease, defined as requiring daily administration of anti-anginal drugs or as New York Heart Association Class III or IV heart failure
  • malignancy of any type in any anatomical location

Key Trial Info

Start Date :

August 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2012

Estimated Enrollment :

2 Patients enrolled

Trial Details

Trial ID

NCT00865514

Start Date

August 1 2011

End Date

January 1 2012

Last Update

June 3 2015

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Florida

Gainesville, Florida, United States, 32610

Pharmacotoxicology of Trichloroethylene Metabolites | DecenTrialz