Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

CYP2B6 Polymorphisms in Ketamine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01988922
Recruitment Status : Completed
First Posted : November 20, 2013
Results First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Healthy Volunteers
Intervention Drug: ketamine
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine Arm- *1/*1 Ketamine Arm - *1/*6 Ketamine Arm - *6/*6
Hide Arm/Group Description

1.*1/*1- oral racemic ketamine 0.4 mg/kg

ketamine: 0.4 mg/kg oral racemic ketamine as a one-time dose

2. *1/*6- oral racemic ketamine 0.4 mg/kg

ketamine: 0.4 mg/kg oral racemic ketamine as a one-time dose

3. *6/*6- oral racemic ketamine 0.4 mg/kg

ketamine: 0.4 mg/kg oral racemic ketamine as a one-time dose

Period Title: Overall Study
Started 10 10 10
Completed 10 10 10
Not Completed 0 0 0
Arm/Group Title Ketamine Arm- *1/*1 Ketamine Arm - *1/*6 Ketamine Arm - *6/*6 Total
Hide Arm/Group Description

1.*1/*1- oral racemic ketamine 0.4 mg/kg

ketamine: 0.4 mg/kg oral racemic ketamine

2. *1/*6- oral racemic ketamine 0.4 mg/kg

ketamine: 0.4 mg/kg oral racemic ketamine

3. *6/*6- oral racemic ketamine 0.4 mg/kg

ketamine: 0.4 mg/kg oral racemic ketamine

Total of all reporting groups
Overall Number of Baseline Participants 10 10 10 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
10
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 10 participants 30 participants
25  (6) 27  (11) 37  (13) 29  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 30 participants
Female
3
  30.0%
4
  40.0%
4
  40.0%
11
  36.7%
Male
7
  70.0%
6
  60.0%
6
  60.0%
19
  63.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 10 participants 30 participants
10 10 10 10
1.Primary Outcome
Title The Effects of CYP2B6 Genetic Variants on Ketamine Metabolism and Clearance by CYP2B6*6 Hetero or Homozygote Genotype.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
3 genotype groups, metabolism measured for both R- and S-ketamine
Arm/Group Title R-ketamine *1/*1 S-ketamine *1/*1 R-ketamine *1/*6 S-ketamine *1/*6 R-ketamine *6/*6 S-ketamine *6/*6
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 10 10 10 10 10 10
Mean (Standard Deviation)
Unit of Measure: ng/ml*hr
29  (10) 21  (7) 26  (11) 19  (10) 35  (21) 23  (13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection R-ketamine *1/*1, S-ketamine *1/*1, R-ketamine *1/*6, S-ketamine *1/*6, R-ketamine *6/*6, S-ketamine *6/*6
Comments [Not Specified]
Type of Statistical Test Other
Comments Differences between CYP2B6*1/*1, CYP2B6*1/*6, and CYP2B6*6/*6 genotypes for pharmacokinetic parameters were analyzed using one-way ANOVA followed by the Student–Newman–Keuls test for multiple comparisons (Sigmaplot 12.5; Systat Software, Inc, USA). Nonnormal data were log transformed for analysis but reported as the nontransformed results.
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments One-way ANOVA followed by the Student–Newman–Keuls test for multiple comparisons
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Arm- *1/*1 Ketamine Arm - *1/*6 Ketamine Arm - *6/*6
Hide Arm/Group Description

1.*1/*1- oral racemic ketamine 0.4 mg/kg

ketamine: 0.4 mg/kg oral racemic ketamine

2. *1/*6- oral racemic ketamine 0.4 mg/kg

ketamine: 0.4 mg/kg oral racemic ketamine

3. *6/*6- oral racemic ketamine 0.4 mg/kg

ketamine: 0.4 mg/kg oral racemic ketamine

All-Cause Mortality
Ketamine Arm- *1/*1 Ketamine Arm - *1/*6 Ketamine Arm - *6/*6
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ketamine Arm- *1/*1 Ketamine Arm - *1/*6 Ketamine Arm - *6/*6
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine Arm- *1/*1 Ketamine Arm - *1/*6 Ketamine Arm - *6/*6
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lesley K Rao
Organization: Washington University in St. Louis School of Medicine
Phone: 3143690683
EMail: raol@wustl.edu
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01988922     History of Changes
Other Study ID Numbers: 201307034
First Submitted: November 13, 2013
First Posted: November 20, 2013
Results First Submitted: February 16, 2018
Results First Posted: May 18, 2018
Last Update Posted: May 18, 2018