Pharmacotoxicology of Trichloroethylene Metabolites

University of Florida

Status and phase: Completed; Phase 2; Phase 1

Conditions: Healthy

Treatments: Drug: Dichloroacetate environmental dose; Drug: Dichloroacetate therapeutic dose; Drug: Chloral Hydrate environmental dose; Drug: Chloral Hydrate therapeutic dose

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01128270

IRB#107-10

RO1ESO141617 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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

Enrollment: 27 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy
• normal screening labs

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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27 participants in 4 patient groups

1A: Chloral Hydrate and DCA: Env

Experimental group

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. (Period 1)

Treatment:

Drug: Chloral Hydrate environmental dose

Drug: Dichloroacetate environmental dose

1B: Chloral Hydrate Env dose

Experimental group

Description:

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)

Treatment:

Drug: Chloral Hydrate environmental dose

2A: Chloral Hydrate and DCA therapeutic

Experimental group

Description:

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)

Treatment:

Drug: Chloral Hydrate therapeutic dose

Drug: Dichloroacetate therapeutic dose

2B: Chloral Hydrate Therapeutic

Experimental group

Description:

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

Treatment:

Drug: Chloral Hydrate therapeutic dose