CYP2B6 Polymorphisms in Ketamine

Healthy Volunteers Clinical Trial

Official title:

Role of CYP2B6 Polymorphisms in Ketamine Metabolism and Clearance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988922
• Other study ID #: 201307034
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: May 2017

Study information

• Verified date: April 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ketamine
0.4 mg/kg oral racemic ketamine

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	up to 24 hours