CYP2B6 Polymorphisms in Ketamine

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: ketamine

• Registration Number: NCT01988922
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes ketamine.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-20
• Primary Completion: 2016-05
• Study Completion: 2017-05
• Results First Submitted: 2018-02-16
• Status Verified: 2018-04
• Results First Submitted QC: 2018-04-13
• Last Update Submitted: 2018-04-13
• Results First Posted: 2018-05-18
• Last Update Posted: 2018-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketamine arm- *1/*1	ketamine	1.\*1/\*1- oral racemic ketamine 0.4 mg/kg
Ketamine arm - *6/*6	ketamine	3. \*6/\*6- oral racemic ketamine 0.4 mg/kg
Ketamine arm - *1/*6	ketamine	2. \*1/\*6- oral racemic ketamine 0.4 mg/kg

Primary Outcome Measures

Name	Time	Method
The Effects of CYP2B6 Genetic Variants on Ketamine Metabolism and Clearance by CYP2B6*6 Hetero or Homozygote Genotype.	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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States