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Trial Outcomes & Findings for CYP2B6 Polymorphisms in Ketamine (NCT NCT01988922)

NCT ID: NCT01988922

Last Updated: 2018-05-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

up to 24 hours

Results posted on

2018-05-18

Participant Flow

Participant milestones

Participant milestones
Measure
Ketamine Arm - *1/*6
2\. \*1/\*6- oral racemic ketamine 0.4 mg/kg ketamine: 0.4 mg/kg oral racemic ketamine as a one-time dose
Ketamine Arm - *6/*6
3\. \*6/\*6- oral racemic ketamine 0.4 mg/kg ketamine: 0.4 mg/kg oral racemic ketamine as a one-time dose
Ketamine Arm- *1/*1
1.\*1/\*1- oral racemic ketamine 0.4 mg/kg ketamine: 0.4 mg/kg oral racemic ketamine as a one-time dose
Overall Study
STARTED
10
10
10
Overall Study
COMPLETED
10
10
10
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CYP2B6 Polymorphisms in Ketamine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ketamine Arm- *1/*1
n=10 Participants
1.\*1/\*1- oral racemic ketamine 0.4 mg/kg ketamine: 0.4 mg/kg oral racemic ketamine
Ketamine Arm - *1/*6
n=10 Participants
2\. \*1/\*6- oral racemic ketamine 0.4 mg/kg ketamine: 0.4 mg/kg oral racemic ketamine
Ketamine Arm - *6/*6
n=10 Participants
3\. \*6/\*6- oral racemic ketamine 0.4 mg/kg ketamine: 0.4 mg/kg oral racemic ketamine
Total
n=30 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
n=5 Participants
10 Participants
n=7 Participants
10 Participants
n=5 Participants
30 Participants
n=4 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Continuous
25 years
STANDARD_DEVIATION 6 • n=5 Participants
27 years
STANDARD_DEVIATION 11 • n=7 Participants
37 years
STANDARD_DEVIATION 13 • n=5 Participants
29 years
STANDARD_DEVIATION 10 • n=4 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
4 Participants
n=7 Participants
4 Participants
n=5 Participants
11 Participants
n=4 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
6 Participants
n=7 Participants
6 Participants
n=5 Participants
19 Participants
n=4 Participants
Region of Enrollment
United States
10 participants
n=5 Participants
10 participants
n=7 Participants
10 participants
n=5 Participants
10 participants
n=4 Participants

PRIMARY outcome

Timeframe: up to 24 hours

Population: 3 genotype groups, metabolism measured for both R- and S-ketamine

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.

Outcome measures

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

Adverse Events

Ketamine Arm- *1/*1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Ketamine Arm - *1/*6

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Ketamine Arm - *6/*6

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lesley K Rao

Washington University in St. Louis School of Medicine

Phone: 3143690683

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place