CYP2B6 Polymorphisms in Ketamine
Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: ketamine (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Washington University School of Medicine Official(s) and/or principal investigator(s):
Evan D Kharach, MD, PhD, Principal Investigator, Affiliation: Washington University School of Medicine
Overall contact:
Jane Blood, RN, Phone: 314-747-5531, Email: bloodj@anest.wustl.edu
Summary
This research study will determine if genetic variation in CYP2B6 affects how the body
metabolizes ketamine.
Clinical Details
Official title: Role of CYP2B6 Polymorphisms in Ketamine Metabolism and Clearance
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: The effects of CYP2B6 genetic variants on ketamine metabolism and clearance by CYP2B6*6 hetero or homozygote genotype.
Secondary outcome: ketamine concentrationnorketamine formation clearances and by genotype
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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)
Locations and Contacts
Jane Blood, RN, Phone: 314-747-5531, Email: bloodj@anest.wustl.edu
Washington University School of Medicine, St. Louis, Missouri 63110, United States; Recruiting
Evan D Kharasch, MD, PhD, Principal Investigator
Additional Information
Starting date: November 2013
Last updated: December 9, 2014
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