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| ID | Type | Description | Link |
|---|---|---|---|
| RO1ESO141617 | Other Grant/Funding Number | National Institute of Health RO1ESO14167 |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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) |
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| 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) |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dichloroacetate environmental dose | Drug | On day 6 they receive Dichloroacetate 2.5 ug/kg orally times 1 and have pharmacokinetics. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter W. Stacpoole, PhD, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida College of Medicine | Gainesville | Florida | 32610 | United States |
There were 27 total participants, with 4 eligible sessions (periods) for each, with the order to be randomized. As per CT.Gov instructions, the periods are identified by treatment rather than order.There were no planned comparisons between the arms of this pharmacological study. Withdrawals entered but did not reach baseline.
Subjects were recruited using an ad approved by the Institutional Review Board (IRB) and by undergoing a screening exam to determine eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | The intent was to have all subjects participate in all four sessions (periods). These were environmental chloral hydrate +/- environmental DCA and therapeutic chloral hydrate +/- therapeutic DCA. Patient participation: 4 Sessions (N=2), 3 Sessions (N=1), 2 Sessions (N=6), 1 Session (N=8), 0 Sessions (N=10), Total: N=27 patients participated in 31 sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Environment Chloral Hydrate and DCA (1A) |
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| Environmental Chloral Hydrate (1B) |
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| Therapeutic Chloral Hydrate and DCA (2A) |
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| Therapeutic Chloral Hydrate (2B) |
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Withdrawals before their treatment was to begin, as all were scheduled to participate in all 4 participate.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Intent was to have all subjects participate in all sessions (periods) |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | micrograms/ml | 6 Days |
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Participants were followed for an average of 2 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1A: Chloral Hydrate+DCA (Environmental) | This is Period 1. See description of periods for full details. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal cramps | Reproductive system and breast disorders | Non-systematic Assessment |
Subjects were asked to wait 30 days in between doses of medication. Some of the participants could not wait the entire 4 months to finish the study and thus dropped out before they completed the 4 arms. Ten were enrolled, screened, but did not start
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter W. Stacpoole,MD | University of Florida | (352) 273-9023 | pws@ufl.edu |
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| Chloral Hydrate environmental dose | Drug | Study subjects are given 1.5 ug/kg of Chloral Hydrate for 5 nights and pharmacokinetics are done on night 1 and 5. |
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| Dichloroacetate therapeutic dose | Drug | Subjects receive 25 mg/kg DCA on Day 6. Pharmacokinetics are done on nights 1 and nights 5. |
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| Chloral Hydrate therapeutic dose | Drug | Subject is given 25 mg/kg of Chloral Hydrate for five nights. |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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. | This applies only to Arm 2B (Therapeutic Chloral Hydrate without DCA. | Posted | Mean | Standard Deviation | minutes | 5 days |
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| Primary | 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. | all eligible participants to arm 2B (Period 4) | Posted | Mean | Standard Deviation | micrograms per ml clorohydrate | 5 days |
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| Secondary | 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. | All eligible session completers | Posted | Number | participants | 1 day |
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| 0 |
| 7 |
| 2 |
| 7 |
| EG001 | Chloral Hydrate (Environmental) | This is Period 2. See description of periods for full details. | 0 | 8 | 3 | 8 |
| EG002 | Chloral Hydrate +DCA (Therapeutic Dose) | This is Period 3. See description of periods for full details. | 0 | 8 | 2 | 8 |
| EG003 | Chloral Hydrate (Therapeutic Dose) | This is Period 4 See description of periods for full details. | 0 | 8 | 2 | 8 |
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Elevated liver enzymes | Hepatobiliary disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| High Blood Pressure | Renal and urinary disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Sore Throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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