This trial is active, not recruiting.

Condition healthy volunteers
Treatment ketamine
Sponsor Washington University School of Medicine
Start date November 2013
End date May 2016
Trial size 32 participants
Trial identifier NCT01988922, 201307034


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
1. oral racemic ketamine 0.4 mg/kg
ketamine Ketalar
0.4 mg/kg oral racemic ketamine

Primary Outcomes

The effects of CYP2B6 genetic variants on ketamine metabolism and clearance by CYP2B6*6 hetero or homozygote genotype.
time frame: up to 24 hours

Secondary Outcomes

ketamine concentration
time frame: up to 24 hours
norketamine formation clearances and by genotype
time frame: up to 24 hours

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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)

Additional Information

Official title Role of CYP2B6 Polymorphisms in Ketamine Metabolism and Clearance
Principal investigator Evan D Kharach, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.