PainPhase 2NCT02857361
Crossover Study to Evaluate the PK Effects of Two Different Wafer Administration Protocols.
A Phase 2 study testing Sublingual ketamine wafers in people with Pain, run by iX Biopharma Ltd. at 1 site in Australia.
Trial summary
The study will look at whether it is preferable to administer two wafers simultaneously or separately. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Sublingual ketamine wafers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2016to Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- 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);
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- Not lactating;
- Not planning to become pregnant during the study;
- 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.
Who cannot join
- 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.
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- History of severe allergic or anaphylactic drug-related reactions.
- History of hypersensitivity to ketamine or any of the excipients of Wafermine™.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
The study will look at whether it is preferable to administer two wafers simultaneously or separately.
- Conditions
- Pain
- Being tested
- Sublingual ketamine wafers
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual ketamine wafersDrug
Also called Wafermine
Two sublingual ketamine 25 mg wafers
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: Simultaneous Administration | Experimental | Sublingual ketamine 50mg (2 x 25mg wafers) administered simultaneously at T=0 minute. Receives: Drug: Sublingual ketamine wafers |
| Treatment B: Sequential Administration | Experimental | 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. Receives: Drug: Sublingual ketamine wafers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability
Plasma concentrations collected for 10 hours after simultaneous wafer administration and sequential wafer administration
Measured: 10 hours
Secondary outcomes (3)
Number of treatment related adverse events
Measured: From time of initial dose until 3 days after final dose.
Participant Acceptance
Participant will rate their experience by completing a questionnaire 20 minutes after each dose.
Measured: 20 minutes
Administrator Acceptance
The person administering drug will rate their experience by completing a questionnaire 20 minutes after each dose.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- iX Biopharma Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sam Salman, MD, Principal investigator, iX Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857361
- Sponsor's protocol ID
- KET011
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT02857361
- Acronym / sponsor ID
- KET011
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- iX Biopharma Ltd.University, hospital or other
- Study start
- Jul 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will look at whether it is preferable to administer two wafers simultaneously or separately.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A: Simultaneous Administration | Experimental | Drug: Sublingual ketamine wafersSublingual ketamine 50mg (2 x 25mg wafers) administered simultaneously at T=0 minute. |
| Treatment B: Sequential Administration | Experimental | Drug: Sublingual ketamine wafersSublingual 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sublingual ketamine wafersAlso: WafermineTwo sublingual ketamine 25 mg wafers | Drug | Treatment A: Simultaneous Administration, Treatment B: Sequential Administration |
Primary outcome
Bioavailability
Time frame: 10 hours
Plasma concentrations collected for 10 hours after simultaneous wafer administration and sequential wafer administration
3 secondary outcomes
Number of treatment related adverse events
Time frame: From time of initial dose until 3 days after final dose.
Participant Acceptance
Time frame: 20 minutes
Administrator Acceptance
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam Salman, MD principal investigator
iX Biopharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sublingual ketamine wafers in people with Pain, run by iX Biopharma Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioavailability (time frame: 10 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016.