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Study of Ketamine Administered Intravenously and by Sublingual Wafer

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ClinicalTrials.gov Identifier: NCT01377831
Recruitment Status : Completed
First Posted : June 21, 2011
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):
iX Biopharma Ltd.

Tracking Information
First Submitted Date June 19, 2011
First Posted Date June 21, 2011
Last Update Posted Date March 10, 2015
Study Start Date June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 6, 2015)
Bioavailability of a single 25 mg dose of sublingual (SL) ketamine [ Time Frame: 24 hours post-dose for two dosing periods, which were separated by 7 days. ]
Bioavailability determined by evaluation and comparison of PK variables following SL and IV administration.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: March 6, 2015)
  • General clinical tolerability and safety [ Time Frame: 24 hours post-dose for two dosing periods, which were separated by 7 days. ]
    Determined by using a range of objective and subjective parameters.
  • Rate of disintegration [ Time Frame: 5 minutes post-dose ]
    Measured the apparent rate of disintegration of a single 25 mg sublingual wafer formulation of ketamine.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Ketamine Administered Intravenously and by Sublingual Wafer
Official Title An Open Label, Two Way Crossover Study to Evaluate the Bioavailability and Clinical Tolerability of a Novel Sublingual Wafer Formulation of Ketamine in Healthy Male Volunteers
Brief Summary To determine the rate and extent of of absorption of racemic ketamine from sublingual wafer
Detailed Description
  1. To determine the apparent rate of disintegration of the sublingual wafer
  2. To determine the overall clinical tolerability of ketamine when administered as a single dose via the sublingual route. Tolerability will be assessed using a range of objective and subjective parameters as assessed using modified Likert and Bond and Lader scales.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood will be drawn into Vacuette brand, lithium heparin separator tubes (green/yellow top).
Sampling Method Probability Sample
Study Population 8 Healthy Male Volunteers
Condition Pain
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 20, 2011)
8
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Adult males aged 18-65 years.
  2. Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the Principal Investigator.
  3. Good general mental health as determined by scores on the Symptom Checklist-90-R (SCL-90-R®), a screening instrument which evaluates a broad range of psychological problems and symptoms of psychopathology.
  4. Agree to and be capable of signing an Informed Consent Form.
  5. Have suitable venous access for blood sampling.
  6. BMI within the range of 19-30 kg/m2.

Exclusion Criteria:

  1. Renal impairment as evidenced by estimated creatinine clearance (CrCl), measured by the Cockcroft-Gault method, of less than 90 mL/min.
  2. Have a laboratory value at the Screening Visit that is outside the normal range, unless it is judged by the Investigator as not clinically significant after appropriate evaluation.
  3. A score of more than two standard deviations from the mean on any of the key nine scales in the SCL-90-R ®
  4. Any medical condition that in the opinion of the Investigator may adversely impact on the participant's ability to complete the study, including but not limited to:

    • History of cerebral trauma or stroke
    • History of seizure or epilepsy
    • Hyperthyroidism
    • Recent clinically significant URTI (within two weeks of Day 1) or respiratory infection
    • History of Myocardial Infarction or clinically significant cardiac disease including cardiac arrhythmia.
    • Poorly controlled hypertension - as assessed by the Principal Investigator.
    • Clinically significant history of asthma requiring regular supportive or preventative therapy (childhood asthma that has resolved >5 years previously may be suitable for inclusion at the discretion of the Investigator.
    • Glaucoma
  5. Plasma AST, ALT and ALP tests in excess of 1.5 times the upper limit of normal.
  6. History of severe allergic or anaphylactic drug-related reactions.
  7. History of hypersensitivity to ketamine or any of its excipients.
  8. Current (within the last six months) clinically significant psychiatric disorder including anxiety, psychosis or depression.
  9. Concurrent use of other medication on a regular or daily basis including but not limited to, theophylline, benzodiazepines, thyroxine, sedatives or anti-anxiolytics.
  10. Participation in another clinical trial of an investigational agent within 30 days of study entry.
  11. Known history of past or present infection with hepatitis C virus (HCV), hepatitis B or human immunodeficiency virus (HIV).
  12. Clinically significant abnormal ECG (12-lead) at the screening visit or prior to dosing on Day 1, as determined by the Investigator.
  13. Participants who have a marked prolongation of the QT corrected (QTc) interval (i.e., repeated demonstration of a QTc >430 msec for males) at screening or prior to dosing on Day 1 in either study period will not be allowed to continue in the study.
  14. Significant history of illicit drug or alcohol use or abuse (as determined by the Principal Investigator).
  15. Any alcohol use within 24 hours prior to dosing on Day 1 in each of the study periods.
  16. Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the participant returning for follow-up visits on schedule.
  17. Blood donation (1 unit or more) within 1 month prior to the screening visit.
  18. Current or previous tobacco user (within 12 months prior to Day 1) .
  19. Planned surgical procedure requiring general anaesthesia during the study period and within two weeks of study completion
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia
Removed Location Countries  
 
Administrative Information
NCT Number NCT01377831
Other Study ID Numbers KET001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party iX Biopharma Ltd.
Study Sponsor iX Biopharma Ltd.
Collaborators Not Provided
Investigators
Principal Investigator: Pual Rolan Pain and Anaesthesia Research Clinic - PARC
PRS Account iX Biopharma Ltd.
Verification Date March 2015