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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02857361




Registration number
NCT02857361
Ethics application status
Date submitted
2/08/2016
Date registered
5/08/2016
Date last updated
19/08/2016

Titles & IDs
Public title
Crossover Study to Evaluate the PK Effects of Two Different Wafer Administration Protocols.
Scientific title
An Open Label, Two-way Crossover Study to Evaluate the PK Effects of Two Different Wafer Administration Protocols in Healthy Volunteers Under Fasted Conditions.
Secondary ID [1] 0 0
KET011
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
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sublingual ketamine wafers

Experimental: Treatment A: Simultaneous Administration - Sublingual ketamine 50mg (2 x 25mg wafers) administered simultaneously at T=0 minute.

Experimental: Treatment B: Sequential Administration - Sublingual ketamine 50mg (2 x 25mg wafers) administered sequentially, one 25 mg wafer at T=0 minute and one 25 mg wafer at T=3 minutes.


Treatment: Drugs: Sublingual ketamine wafers
Two sublingual ketamine 25 mg wafers

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Bioavailability - Plasma concentrations collected for 10 hours after simultaneous wafer administration and sequential wafer administration
Timepoint [1] 0 0
10 hours
Secondary outcome [1] 0 0
Number of treatment related adverse events
Timepoint [1] 0 0
From time of initial dose until 3 days after final dose.
Secondary outcome [2] 0 0
Participant Acceptance - Participant will rate their experience by completing a questionnaire 20 minutes after each dose.
Timepoint [2] 0 0
20 minutes
Secondary outcome [3] 0 0
Administrator Acceptance - The person administering drug will rate their experience by completing a questionnaire 20 minutes after each dose.
Timepoint [3] 0 0
20 minutes

Eligibility
Key inclusion criteria
- Males or females aged 18-65 years.

- Good general health without clinically significant renal, hepatic, cardiac or
respiratory disease, as determined by the Principal Investigator.

- Willing and able to give informed consent and agree to complete all study procedures.

- Have suitable venous access for blood sampling.

- Female participants are eligible only if all the following apply:

1. Not pregnant (women of child bearing potential must have a negative serum
pregnancy test at screening and negative urine pregnancy test at check-in for
each inpatient period);

2. Not lactating;

3. Not planning to become pregnant during the study;

4. Be surgically sterile (irreversible surgical sterilisation by hysterectomy,
bilateral oophorectomy, or bilateral salpingectomy), or have undergone bilateral
tubal ligation; or be at least two years post-menopausal; or is practicing
double-barrier contraception or is using an insertable, injectable, transdermal,
or combination oral contraceptive for greater than 2 months prior to screening
visits and commits to the use of an acceptable form of highly effective birth
control for the duration of the study and for 30 days after the last dose study
drug administration.

- BMI within the range of 19-30 kg/m2 (inclusive).

- Deemed able to read and understand English in order to communicate with research staff
and complete protocol required questionnaires and forms.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Has 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. One repeat of initial laboratory testing is allowed.

- AST, ALT and ALP tests in excess of 1.5 times the upper limit of normal.

- Any gastrointestinal condition that could affect drug absorption.

- History of any clinically significant condition involving the bladder or urinary
tract, including frequent urinary tract infections (e.g. > 2 per year), or current
symptoms of bladder irritation such as frequent or urgent need to urinate or burning
with urination.

- History (within the last six months) of or current clinically significant psychiatric
disorder including anxiety, psychosis or depression.

- Current inflammatory or ulcerative disease of the oral cavity that could impair the
absorption of sublingual medication.

- History of severe allergic or anaphylactic drug-related reactions.

- History of hypersensitivity to ketamine or any of the excipients of Wafermineâ„¢.

- Intake of any prescribed or Over-The-Counter (OTC)/non-prescribed drugs, vitamins,
supplements or herbal medicines, within 2 weeks of administration of investigational
product (or longer if the medication has a half-life long enough to potentially expose
the healthy participant to any significant systemic exposure). Exception: Hormone
replacement therapy and oral contraceptives in female participants is allowed.

- Use of drugs with enzyme-inducing properties, such as rifampicin and St John's Wort,
within 3 weeks or 5 half-lives, whichever is greater, prior to treatment period 1 and
throughout the study, or any drug known to be a strong inhibitor of CYP3A4 within 5
half-lives of treatment period 1 and throughout the study.

- Participation in another clinical trial of an investigational agent within 30 days of
screening.

- Positive serology for hepatitis C virus (HCV), hepatitis B or human immunodeficiency
virus (HIV).

- Clinically significant, as determined by the Investigator, abnormal ECG (12-lead) or
vital signs at the screening visit or pre-dose on any treatment day.

- Known or suspected drug (including analgesic drugs or tranquilizers) or alcohol abuse
or dependence, as defined by DSM-IV, and not in full remission, as judged by the
Investigator, or history of alcohol abuse or excessive intake of alcohol, defined as
regular weekly intake of >15 units for men and >10 units for women. (1 unit = 25 mL
spirits, 125 mL wine, 250 mL beer or lager.)

- Positive results on the urine drug screen or breath alcohol test at screening and/or
pre-dose. A positive result on the urinary drug screen at screening is allowed at the
discretion of the Investigator provided the result can be reliably explained by recent
medication and/or dietary history.

- Significant history of illicit drug use (as determined by the Investigator).

- Any alcohol use within 24 hours prior to each inpatient treatment period.

- 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 subsequent visits on schedule.

- Blood donation (1 unit or more) within 1 month prior to the screening visit and until
the end of study participation.

- Current or previous tobacco user (within 12 months prior to screening).

- Participants who routinely consume more than four standard caffeinated beverages per
24-hour period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint(s)
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)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

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

Ethics approval
Ethics application status

Summary
Brief summary
The study will look at whether it is preferable to administer two wafers simultaneously or
separately.
Trial website
https://clinicaltrials.gov/show/NCT02857361
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sam Salman, MD
Address 0 0
iX Biopharma
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