Pharmacotoxicology of Trichloroethylene Metabolites

NCT ID: NCT01128270

Last Updated: 2014-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2012-10-31

Brief Summary

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

Detailed Description

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 2.5 micrograms/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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

1A: Chloral Hydrate and DCA: Env

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. (Period 1)

Group Type: EXPERIMENTAL

Dichloroacetate environmental dose

Intervention Type: DRUG

On day 6 they receive Dichloroacetate 2.5 ug/kg orally times 1 and have pharmacokinetics.

Chloral Hydrate environmental dose

Intervention Type: DRUG

Study subjects are given 1.5 ug/kg of Chloral Hydrate for 5 nights and pharmacokinetics are done on night 1 and 5.

1B: Chloral Hydrate Env dose

Drug Study Subjects are admitted to the clinical research unit and receive 1.5 ug/kg (environmental dose) of Chloral Hydrate for 5 nights. Pharmacokinetics are done on days 1 and day 5. (Period 2)

Group Type: EXPERIMENTAL

Chloral Hydrate environmental dose

Intervention Type: DRUG

Study subjects are given 1.5 ug/kg of Chloral Hydrate for 5 nights and pharmacokinetics are done on night 1 and 5.

2A: Chloral Hydrate and DCA therapeutic

Drug Study Subjects are admitted to the clinical research center and receive a clinical dose of Chloral Hydrate for 5 nights (25mg/kg). On day 6 they are given a clinical dose (25mg/kg)of Dichloroacetate. (Period 3)

Group Type: EXPERIMENTAL

Dichloroacetate therapeutic dose

Intervention Type: DRUG

Subjects receive 25 mg/kg DCA on Day 6. Pharmacokinetics are done on nights 1 and nights 5.

Chloral Hydrate therapeutic dose

Intervention Type: DRUG

Subject is given 25 mg/kg of Chloral Hydrate for five nights.

2B: Chloral Hydrate Therapeutic

Subjects are given 25 mg/kg of Chloral Hydrate for five nights. Pharmacokinetics are done on days 1 and 5. (Period 4)

Group Type: EXPERIMENTAL

Chloral Hydrate therapeutic dose

Intervention Type: DRUG

Subject is given 25 mg/kg of Chloral Hydrate for five nights.

Interventions

Dichloroacetate environmental dose

On day 6 they receive Dichloroacetate 2.5 ug/kg orally times 1 and have pharmacokinetics.

Intervention Type: DRUG

Chloral Hydrate environmental dose

Study subjects are given 1.5 ug/kg of Chloral Hydrate for 5 nights and pharmacokinetics are done on night 1 and 5.

Intervention Type: DRUG

Dichloroacetate therapeutic dose

Subjects receive 25 mg/kg DCA on Day 6. Pharmacokinetics are done on nights 1 and nights 5.

Intervention Type: DRUG

Chloral Hydrate therapeutic dose

Subject is given 25 mg/kg of Chloral Hydrate for five nights.

Intervention Type: DRUG

Other Intervention Names

DCA; DCA

Eligibility Criteria

Inclusion Criteria

• healthy
• normal screening labs

Exclusion Criteria

• no gastrointestinal surgery
• no smoking
• no medication
• not pregnant

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter W. Stacpoole, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida College of Medicine

Gainesville, Florida, United States

Countries

United States

Other Identifiers

RO1ESO141617

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB#107-10

Identifier Type: -

Identifier Source: org_study_id