CYP2B6 Polymorphisms in Ketamine
Role of CYP2B6 Polymorphisms in Ketamine Metabolism and Clearance
1 other identifier
interventional
30
1 country
1
Brief Summary
This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes ketamine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy-volunteers
Started Nov 2013
Longer than P75 for not_applicable healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 13, 2013
CompletedFirst Posted
Study publicly available on registry
November 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
May 18, 2018
CompletedMay 18, 2018
April 1, 2018
2.5 years
November 13, 2013
February 16, 2018
April 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Ketamine arm- *1/*1
EXPERIMENTAL1.\*1/\*1- oral racemic ketamine 0.4 mg/kg
Ketamine arm - *1/*6
EXPERIMENTAL2\. \*1/\*6- oral racemic ketamine 0.4 mg/kg
Ketamine arm - *6/*6
EXPERIMENTAL3\. \*6/\*6- oral racemic ketamine 0.4 mg/kg
Interventions
0.4 mg/kg oral racemic ketamine
Eligibility Criteria
You may qualify if:
- yr old
- CYP2B6\*1/\*1, CYP2B6\*1/\*6 or CYP2B6\*6/\*6 genotype (see table) (Note: subjects of other rare genotype but with one or more 516G\>T, 785A\>G, 983T\>C or 1459C\>T polymorphism may be enrolled at PI's discretion)
- Good general health with no remarkable medical conditions
- BMI \<33
- Provided informed consent
You may not qualify if:
- Known history of liver or kidney disease
- Use of prescription or non prescription medications, herbals, foods or chemicals known to be metabolized by or affecting CYP2B6
- Females who are pregnant or nursing
- Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Lesley K Rao
- Organization
- Washington University in St. Louis School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Lesley Rao, MD
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2013
First Posted
November 20, 2013
Study Start
November 1, 2013
Primary Completion
May 1, 2016
Study Completion
May 1, 2017
Last Updated
May 18, 2018
Results First Posted
May 18, 2018
Record last verified: 2018-04