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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01377831




Registration number
NCT01377831
Ethics application status
Date submitted
19/06/2011
Date registered
21/06/2011
Date last updated
10/03/2015

Titles & IDs
Public title
Study of Ketamine Administered Intravenously and by Sublingual Wafer
Scientific 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
Secondary ID [1] 0 0
KET001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Bioavailability of a single 25 mg dose of sublingual (SL) ketamine - Bioavailability determined by evaluation and comparison of PK variables following SL and IV administration.
Timepoint [1] 0 0
24 hours post-dose for two dosing periods, which were separated by 7 days.
Secondary outcome [1] 0 0
General clinical tolerability and safety - Determined by using a range of objective and subjective parameters.
Timepoint [1] 0 0
24 hours post-dose for two dosing periods, which were separated by 7 days.
Secondary outcome [2] 0 0
Rate of disintegration - Measured the apparent rate of disintegration of a single 25 mg sublingual wafer formulation of ketamine.
Timepoint [2] 0 0
5 minutes post-dose

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Pain and Anaesthesia Research Clinic (PARC), Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
iX Biopharma Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To determine the rate and extent of of absorption of racemic ketamine from sublingual wafer
Trial website
https://clinicaltrials.gov/show/NCT01377831
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pual Rolan
Address 0 0
Pain and Anaesthesia Research Clinic - PARC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications