CompletedNCT01988922Updated May 18, 2018Results posted

CYP2B6 Polymorphisms in Ketamine

An interventional study of ketamine in Healthy Volunteers, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-18.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 30
Allocation: Non-randomized
Ages: 18 Years to 50 Years
Sex: All

Study summary

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

Conditions studied

Healthy Volunteers

Keywords

ketamine polymorphisms

In context

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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)

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 30 participants (actual)

Study arms

Experimental
Ketamine arm- *1/*1
1.\*1/\*1- oral racemic ketamine 0.4 mg/kg
Drug: ketamine
Experimental
Ketamine arm - *1/*6
2. \*1/\*6- oral racemic ketamine 0.4 mg/kg
Drug: ketamine
Experimental
Ketamine arm - *6/*6
3. \*6/\*6- oral racemic ketamine 0.4 mg/kg
Drug: ketamine

Interventions

Drugketamine
0.4 mg/kg oral racemic ketamine

What researchers measure

Primary outcomes

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.
Time frame: up to 24 hours

Results

Posted May 18, 2018

Participant flow

Participant flow — Overall Study
Milestone	Ketamine Arm- 1/1	Ketamine Arm - 1/6	Ketamine Arm - 6/6
Started	10	10	10
Completed	10	10	10
Not completed	0	0	0

Outcome measures

PrimaryThe 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.

Time frame:: up to 24 hours
Reported as:: Mean · ng/ml*hr

The Effects of CYP2B6 Genetic Variants on Ketamine Metabolism and Clearance by CYP2B6*6 Hetero or Homozygote Genotype.
ng/ml*hr	R-ketamine 1/1	S-ketamine 1/1	R-ketamine 1/6	S-ketamine 1/6	R-ketamine 6/6	S-ketamine 6/6
The Effects of CYP2B6 Genetic Variants on Ketamine Metabolism and Clearance by CYP2B6*6 Hetero or Homozygote Genotype.	29 ± 10	21 ± 7	26 ± 11	19 ± 10	35 ± 21	23 ± 13

Statistical analysis

R-ketamine *1/*1 vs S-ketamine *1/*1 vs R-ketamine *1/*6 vs S-ketamine *1/*6 vs R-ketamine *6/*6 vs S-ketamine *6/*6 · ANOVA · p = <0.05One-way ANOVA followed by the Student-Newman-Keuls test for multiple comparisons

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Ketamine Arm- 1/1	—	0/10 (0%)	0/10 (0%)
Ketamine Arm - 1/6	—	0/10 (0%)	0/10 (0%)
Ketamine Arm - 6/6	—	0/10 (0%)	0/10 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Ketamine Arm- 1/1	Ketamine Arm - 1/6	Ketamine Arm - 6/6	Total
<=18 years	0	0	0	0
Between 18 and 65 years	10	10	10	30
>=65 years	0	0	0	0

Age, Continuous
Age, Continuous(years)	Ketamine Arm- 1/1	Ketamine Arm - 1/6	Ketamine Arm - 6/6	Total
Mean	25 ± 6	27 ± 11	37 ± 13	29 ± 10

Sex: Female, Male
Sex: Female, Male(Participants)	Ketamine Arm- 1/1	Ketamine Arm - 1/6	Ketamine Arm - 6/6	Total
Female	3	4	4	11
Male	7	6	6	19

Region of Enrollment
Region of Enrollment(participants)	Ketamine Arm- 1/1	Ketamine Arm - 1/6	Ketamine Arm - 6/6	Total
United States	10	10	10	10

Study locations

1 site

Washington University School of Medicine
Saint Louis, Missouri 63110, United States

References and documents

Study documents

Study protocol · Jul 9, 2013
Statistical analysis plan · Jul 9, 2013

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01988922
Lead sponsor: Washington University School of Medicine
Responsible party: Sponsor
First posted: Nov 20, 2013
Start date: Nov 2013
Primary completion: May 2016
Completion: May 2017
Results posted: May 18, 2018
Last update: May 18, 2018

Study contacts

Lesley Rao, MD

principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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