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CYP2B6 Polymorphisms in Ketamine

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ClinicalTrials.gov Identifier: NCT01988922
Recruitment Status : Completed
First Posted : November 20, 2013
Results First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE November 13, 2013
First Posted Date  ICMJE November 20, 2013
Results First Submitted Date  ICMJE February 16, 2018
Results First Posted Date  ICMJE May 18, 2018
Last Update Posted Date May 18, 2018
Study Start Date  ICMJE November 2013
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
The Effects of CYP2B6 Genetic Variants on Ketamine Metabolism and Clearance by CYP2B6*6 Hetero or Homozygote Genotype. [ Time Frame: up to 24 hours ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 13, 2013)
The Effects of CYP2B6 Genetic Variants on Ketamine Metabolism and Clearance by CYP2B6*6 Hetero or Homozygote Genotype. [ Time Frame: up to 24 hours ]
This outcome will be measured by blood draws taken during the study days and follow-ups. This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes ketamine.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2013)
  • ketamine concentration [ Time Frame: up to 24 hours ]
    This outcome will be measured by blood and urine collections.
  • norketamine formation clearances and by genotype [ Time Frame: up to 24 hours ]
    This outcome will be measured by blood and urine collections.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CYP2B6 Polymorphisms in Ketamine
Official Title  ICMJE Role of CYP2B6 Polymorphisms in Ketamine Metabolism and Clearance
Brief Summary This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes ketamine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE Drug: ketamine
0.4 mg/kg oral racemic ketamine
Study Arms  ICMJE
  • Experimental: Ketamine arm- *1/*1
    1.*1/*1- oral racemic ketamine 0.4 mg/kg
    Intervention: Drug: ketamine
  • Experimental: Ketamine arm - *1/*6
    2. *1/*6- oral racemic ketamine 0.4 mg/kg
    Intervention: Drug: ketamine
  • Experimental: Ketamine arm - *6/*6
    3. *6/*6- oral racemic ketamine 0.4 mg/kg
    Intervention: Drug: ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2018)
30
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2013)
40
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 18-50 yr old
  2. 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)
  3. Good general health with no remarkable medical conditions
  4. BMI <33
  5. Provided informed consent

Exclusion Criteria:

  1. Known history of liver or kidney disease
  2. Use of prescription or non prescription medications, herbals, foods or chemicals known to be metabolized by or affecting CYP2B6
  3. Females who are pregnant or nursing
  4. Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
  5. Direct physical access to and routine handling of addicting drugs in the regular course of duty (this is a routine exclusion from studies of drugs with addiction potential)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01988922
Other Study ID Numbers  ICMJE 201307034
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lesley Rao, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP