N/A
N=30
CYP2B6 Polymorphisms in Ketamine
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT01988922 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: The Effects of CYP2B6 Genetic Variants on Ketamine Metabolism and Clearance by CYP2B6*6 Hetero or Homozygote Genotype. — 29; 21; 26; 19 ng/ml*hr — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ketamine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Effects of CYP2B6 Genetic Variants on Ketamine Metabolism and Clearance by CYP2B6*6 Hetero or Homozygote Genotype. |
29; 21; 26; 19; 35; 23 | <0.05 sig |
Summary
This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes ketamine.
Eligibility Criteria
Inclusion Criteria
- 18-50 yr old
- 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)
- Good general health with no remarkable medical conditions
- BMI <33
- Provided informed consent
Exclusion Criteria
- Known history of liver or kidney disease
- Use of prescription or non prescription medications, herbals, foods or chemicals known to be metabolized by or affecting CYP2B6
- Females who are pregnant or nursing
- Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
- 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)
Data sourced from ClinicalTrials.gov (NCT01988922). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.