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This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes ketamine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine arm- *1/*1 | Experimental | 1.*1/*1- oral racemic ketamine 0.4 mg/kg |
|
| Ketamine arm - *1/*6 | Experimental | 2. *1/*6- oral racemic ketamine 0.4 mg/kg |
|
| Ketamine arm - *6/*6 | Experimental | 3. *6/*6- oral racemic ketamine 0.4 mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketamine | Drug | 0.4 mg/kg oral racemic ketamine |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Effects of CYP2B6 Genetic Variants on Ketamine Metabolism and Clearance by CYP2B6*6 Hetero or Homozygote Genotype. | Ketamine metabolism, measured as the plasma norketamine/ketamine AUC ratio in CYP2B6*6 carriers (CYP2B6*6 hetero or homozygotes) compared to the wild-type CYP2B6*1/*1 genotype Ketamine, norketamine, and dehydronorketamine concentrations in plasma and urine were determined by enantioselective HPLC tandem mass spectrometry, using solid phase extraction, based on a modification of a published method. | up to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lesley Rao, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine Arm- *1/*1 | 1.*1/*1- oral racemic ketamine 0.4 mg/kg ketamine: 0.4 mg/kg oral racemic ketamine as a one-time dose |
| FG001 | Ketamine Arm - *1/*6 | 2. *1/*6- oral racemic ketamine 0.4 mg/kg ketamine: 0.4 mg/kg oral racemic ketamine as a one-time dose |
| FG002 | Ketamine Arm - *6/*6 | 3. *6/*6- oral racemic ketamine 0.4 mg/kg ketamine: 0.4 mg/kg oral racemic ketamine as a one-time dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine Arm- *1/*1 | 1.*1/*1- oral racemic ketamine 0.4 mg/kg ketamine: 0.4 mg/kg oral racemic ketamine |
| BG001 | Ketamine Arm - *1/*6 | 2. *1/*6- oral racemic ketamine 0.4 mg/kg ketamine: 0.4 mg/kg oral racemic ketamine |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | The Effects of CYP2B6 Genetic Variants on Ketamine Metabolism and Clearance by CYP2B6*6 Hetero or Homozygote Genotype. | Ketamine metabolism, measured as the plasma norketamine/ketamine AUC ratio in CYP2B6*6 carriers (CYP2B6*6 hetero or homozygotes) compared to the wild-type CYP2B6*1/*1 genotype Ketamine, norketamine, and dehydronorketamine concentrations in plasma and urine were determined by enantioselective HPLC tandem mass spectrometry, using solid phase extraction, based on a modification of a published method. | 3 genotype groups, metabolism measured for both R- and S-ketamine | Posted | Mean | Standard Deviation | ng/ml*hr | up to 24 hours |
|
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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 | Ketamine Arm- *1/*1 | 1.*1/*1- oral racemic ketamine 0.4 mg/kg ketamine: 0.4 mg/kg oral racemic ketamine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lesley K Rao | Washington University in St. Louis School of Medicine | 3143690683 | raol@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 9, 2013 | Feb 16, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 9, 2013 | Apr 13, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| BG002 | Ketamine Arm - *6/*6 | 3. *6/*6- oral racemic ketamine 0.4 mg/kg ketamine: 0.4 mg/kg oral racemic ketamine |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | R-ketamine *1/*6 |
| OG003 | S-ketamine *1/*6 |
| OG004 | R-ketamine *6/*6 |
| OG005 | S-ketamine *6/*6 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Ketamine Arm - *1/*6 | 2. *1/*6- oral racemic ketamine 0.4 mg/kg ketamine: 0.4 mg/kg oral racemic ketamine | 0 | 10 | 0 | 10 |
| EG002 | Ketamine Arm - *6/*6 | 3. *6/*6- oral racemic ketamine 0.4 mg/kg ketamine: 0.4 mg/kg oral racemic ketamine | 0 | 10 | 0 | 10 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |