HealthyPhase 1/2NCT01128270
Pharmacotoxicology of Trichloroethylene Metabolites
A Phase 1/2 study testing Dichloroacetate environmental dose, Chloral Hydrate environmental dose and Dichloroacetate therapeutic dose in people with Healthy, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dichloroacetate environmental dose, Chloral Hydrate environmental dose and Dichloroacetate therapeutic dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Oct 2012
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- normal screening labs
Who cannot join
- no gastrointestinal surgery
- no smoking
- no medication
- not pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida College of Medicine
Gainesville, Florida, 32610
About this study
Official title: Pharmacotoxicology of Trichloroethylene Metabolites Aim 3
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
Read the 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
- Being tested
- Dichloroacetate environmental dose, Chloral Hydrate environmental dose, Dichloroacetate therapeutic dose, Chloral Hydrate therapeutic dose
- Keywords
- Dichloroacetate, Chloral Hydrate, Metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dichloroacetate environmental doseDrug
Also called DCA
On day 6 they receive Dichloroacetate 2.5 ug/kg orally times 1 and have pharmacokinetics.
Chloral Hydrate environmental doseDrug
Study subjects are given 1.5 ug/kg of Chloral Hydrate for 5 nights and pharmacokinetics are done on night 1 and 5.
Dichloroacetate therapeutic doseDrug
Also called DCA
Subjects receive 25 mg/kg DCA on Day 6. Pharmacokinetics are done on nights 1 and nights 5.
Chloral Hydrate therapeutic doseDrug
Subject is given 25 mg/kg of Chloral Hydrate for five nights.
| Study group | Role | What they receive |
|---|---|---|
| 1A: Chloral Hydrate and DCA: Env | Experimental | 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) Receives: Drug: Dichloroacetate environmental dose; Drug: Chloral Hydrate environmental dose |
| 1B: Chloral Hydrate Env dose | Experimental | 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) Receives: Drug: Chloral Hydrate environmental dose |
| 2A: Chloral Hydrate and DCA therapeutic | Experimental | 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) Receives: Drug: Dichloroacetate therapeutic dose; Drug: Chloral Hydrate therapeutic dose |
| 2B: Chloral Hydrate Therapeutic | Experimental | Subjects are given 25 mg/kg of Chloral Hydrate for five nights. Pharmacokinetics are done on days 1 and 5. (Period 4) Receives: Drug: Chloral Hydrate therapeutic dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma DCA (Microgram/ml) After 5 Days of Therapeutic Level Chloral Hydrate on Arm 2A.
After 5 days of of therapeutic level Chloral Hydrate, the levels of Dichloroacetate in the plasma were measured.
Measured: 6 Days
Difference in Half Lives 5 Day Less One Day Exposure in Trichloroacetate
Elimination Half-life Difference on Arm 2B for 13C-Labeled trichloroacetate between day 5 (prolonged exposure) and day 1 (de novo exposure) after therapeutic level exposure to Chloral Hydrate. This outcome only applies to Period 4. Trichloroacetate is a marker, not an intervention.
Measured: 5 days
Urinary Maleylacetone Levels After 5 Day Exposure to Therapeutic Chloral Hydrate (Arm 2B)
The levels were clinically indetectable at baseline and the question was whether or not substantive levels would be noted at after 5 days exposure to Chloral Hydrate. Detectable, but low levels were detected.
Measured: 5 days
Secondary outcomes (1)
Detectable DCA After Day 1 in Serum (0=No 1=Yes)
All four arms receive Chloral Hydrate on Day 1 (arms 1A and 1B environmental levels) and (arms 2A and 2B therapeutic levels). The question is could Dichloroacetate be detected in serum at the end of day 1. This analysis is purely descriptive, and no comparisons were planned.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Peter W. Stacpoole, PhD, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128270
- Sponsor's protocol ID
- IRB#107-10
- Other IDs
- RO1ESO141617
- Status last verified
- Apr 2014
- First submitted
- 20 May 2010
- Last updated
- 7 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacotoxicology of Trichloroethylene Metabolites Aim 3
- ClinicalTrials.gov ID
- NCT01128270
- Acronym / sponsor ID
- IRB#107-10
- Conditions
- Healthy
- Keywords
- Dichloroacetate, Chloral Hydrate, Metabolism
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Apr 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 21 May 2010 (estimated)
- Results
- Posted 7 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1A: Chloral Hydrate and DCA: Env | Experimental | Drug: Dichloroacetate environmental dose, Drug: Chloral Hydrate environmental doseSubjects 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) |
| 1B: Chloral Hydrate Env dose | Experimental | Drug: Chloral Hydrate environmental doseDrug 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) |
| 2A: Chloral Hydrate and DCA therapeutic | Experimental | Drug: Dichloroacetate therapeutic dose, Drug: Chloral Hydrate therapeutic doseDrug 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) |
| 2B: Chloral Hydrate Therapeutic | Experimental | Drug: Chloral Hydrate therapeutic doseSubjects are given 25 mg/kg of Chloral Hydrate for five nights. Pharmacokinetics are done on days 1 and 5. (Period 4) |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy
- normal screening labs
Key exclusion criteria (4 listed)
- no gastrointestinal surgery
- no smoking
- no medication
- not pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dichloroacetate environmental doseAlso: DCAOn day 6 they receive Dichloroacetate 2.5 ug/kg orally times 1 and have pharmacokinetics. | Drug | 1A: Chloral Hydrate and DCA: Env |
| Chloral Hydrate environmental doseStudy subjects are given 1.5 ug/kg of Chloral Hydrate for 5 nights and pharmacokinetics are done on night 1 and 5. | Drug | 1A: Chloral Hydrate and DCA: Env, 1B: Chloral Hydrate Env dose |
| Dichloroacetate therapeutic doseAlso: DCASubjects receive 25 mg/kg DCA on Day 6. Pharmacokinetics are done on nights 1 and nights 5. | Drug | 2A: Chloral Hydrate and DCA therapeutic |
| Chloral Hydrate therapeutic doseSubject is given 25 mg/kg of Chloral Hydrate for five nights. | Drug | 2A: Chloral Hydrate and DCA therapeutic, 2B: Chloral Hydrate Therapeutic |
Primary outcome
Plasma DCA (Microgram/ml) After 5 Days of Therapeutic Level Chloral Hydrate on Arm 2A.
Time frame: 6 Days
After 5 days of of therapeutic level Chloral Hydrate, the levels of Dichloroacetate in the plasma were measured.
Difference in Half Lives 5 Day Less One Day Exposure in Trichloroacetate
Time frame: 5 days
Elimination Half-life Difference on Arm 2B for 13C-Labeled trichloroacetate between day 5 (prolonged exposure) and day 1 (de novo exposure) after therapeutic level exposure to Chloral Hydrate. This outcome only applies to Period 4. Trichloroacetate is a marker, not an intervention.
Urinary Maleylacetone Levels After 5 Day Exposure to Therapeutic Chloral Hydrate (Arm 2B)
Time frame: 5 days
The levels were clinically indetectable at baseline and the question was whether or not substantive levels would be noted at after 5 days exposure to Chloral Hydrate. Detectable, but low levels were detected.
1 secondary outcome
Detectable DCA After Day 1 in Serum (0=No 1=Yes)
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter W. Stacpoole, PhD, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dichloroacetate environmental dose, Chloral Hydrate environmental dose and Dichloroacetate therapeutic dose in people with Healthy, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma DCA (Microgram/ml) After 5 Days of Therapeutic Level Chloral Hydrate on Arm 2A. (time frame: 6 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2014.