CYP2B6 Polymorphisms in Ketamine

The Washington University

Status: Completed

Conditions: Healthy Volunteers

Treatments: Drug: ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01988922

201307034

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Ketamine arm- *1/*1

Experimental group

Description:

1.\*1/\*1- oral racemic ketamine 0.4 mg/kg

Treatment:

Drug: ketamine

Ketamine arm - *1/*6

Experimental group

Description:

2. \*1/\*6- oral racemic ketamine 0.4 mg/kg

Treatment:

Drug: ketamine

Ketamine arm - *6/*6

Experimental group

Description:

3. \*6/\*6- oral racemic ketamine 0.4 mg/kg

Treatment:

Drug: ketamine