Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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
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
Sex
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
1/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2011
Sample size
Target
Accrual to date
Final
8
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01377831