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CYP2B6 Polymorphisms in Ketamine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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Brief Summary:
This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes ketamine.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: ketamine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Role of CYP2B6 Polymorphisms in Ketamine Metabolism and Clearance
Study Start Date : November 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ketamine arm- *1/*1
1.*1/*1- oral racemic ketamine 0.4 mg/kg
 Drug: ketamine
0.4 mg/kg oral racemic ketamine
Experimental: Ketamine arm - *1/*6
2. *1/*6- oral racemic ketamine 0.4 mg/kg
 Drug: ketamine
0.4 mg/kg oral racemic ketamine
Experimental: Ketamine arm - *6/*6
3. *6/*6- oral racemic ketamine 0.4 mg/kg
 Drug: ketamine
0.4 mg/kg oral racemic ketamine


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988922


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Lesley Rao, MD Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:
Study Protocol  [PDF] July 9, 2013
Statistical Analysis Plan  [PDF] July 9, 2013

More Information
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01988922    
Other Study ID Numbers: 201307034
First Posted: November 20, 2013    Key Record Dates
Results First Posted: May 18, 2018
Last Update Posted: May 18, 2018
Last Verified: April 2018
Keywords provided by Washington University School of Medicine:
ketamine polymorphisms
Additional relevant MeSH terms:
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Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
 Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action