Expired Study
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Gainesville, Florida 32610


Purpose:

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


Study summary:

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 2.5mg/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


Criteria:

Inclusion Criteria: - healthy - normal screening labs Exclusion Criteria: - no gastrointestinal surgery - no smoking - no medication - not pregnant


Study is Available At:


Original ID:

IRB#107-10


NCT ID:

NCT01128270


Secondary ID:

RO1ESO141617


Study Acronym:


Brief Title:

Pharmacotoxicology of Trichloroethylene Metabolites


Official Title:

Pharmacotoxicology of Trichloroethylene Metabolites Aim 3


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Florida


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

27


Enrollment Type:

Actual


Overall Contact Information

Official Name:Peter W. Stacpoole, PhD, MD
Principal Investigator
University of Florida

Study Dates

Start Date:April 2010
Completion Date:October 2012
Completion Type:Actual
Primary Completion Date:October 2012
Primary Completion Type:Actual
Verification Date:March 2013
Last Changed Date:March 11, 2013
First Received Date:May 20, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Determine the in vivo kinetics and biotransformation of chloral hydrate
Time Frame:10 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Chloral Hydrate and DCA therapeutic
Description:30 days later the subject is given 1 gram of chloral hydrate for five nights and on day 6 25mg/kg. of dichloroacetate and pharmacokinetics are done.
Arm Name:Chloral Hydrate and DCA therapeutic
Other Name:DCA
Intervention Type:Drug
Name:chloral hydrate therapeutic dose
Description:The next arm 30 days apart the subjects receive 1 gram of chloral hydrate for 5 nights and kinetics are done on nights 1 and nights 5.
Arm Name:Chloral Hydrate therapeutic dose
Other Name:DCA
Intervention Type:Drug
Name:Chloral Hydrate
Description:For the second arm of the study subjects are given 1.5mcg/kg of chloral hydrate for 5 nights and pharmacokinetics are done on night 1 and 5.
Arm Name:Chloral Hydrate
Other Name:pharmacokinetics
Intervention Type:Drug
Name:Chloral Hydrate and Dichloroacetate
Description:Subjects are given 1.5mcg/kg of chloral hydrate for 5 nights, On day 6 they receive Dichloroacetate 2.5 mcg/kg orally times 1 and have pharmacokinetics.
Arm Name:Chloral Hydrate and Dichloroacetate
Other Name:Metabolism

Study Arms

Study Arm Type:Experimental
Arm Name:Chloral Hydrate and Dichloroacetate
Description:Subjects consume chloral hydrate 1.5ug/kg by mouth for 5 nights. On the 6th day they consume DCA 2.5ug/kg by mouth and have blood samples drawn
Study Arm Type:Experimental
Arm Name:Chloral Hydrate therapeutic dose
Description:Drug Study Subjects are admitted to the clinical research unit and receive 1 gram (therapeutic dose) of chloral hydrate for 5 nights. Pharmacokinetics are done on days 1 and day 5.
Study Arm Type:Experimental
Arm Name:Chloral Hydrate and DCA therapeutic
Description:Drug Study Subjects are admitted to the clinical research center and receive a clinical dose of chloral hydrate for 5 nights. On day 6 they are given a clinical dose (25mg/kg)of Dichloroacetate
Study Arm Type:Experimental
Arm Name:Chloral Hydrate
Description:Subjects are given 1.5mcg of Chloral Hydrae for five nights and pharmacokinetics are done on days 1 and 5.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Florida
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institutes of Health (NIH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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