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The study will look at whether it is preferable to administer two wafers simultaneously or separately.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: Simultaneous Administration | Experimental | Sublingual ketamine 50mg (2 x 25mg wafers) administered simultaneously at T=0 minute. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sublingual ketamine wafers | Drug | Two sublingual ketamine 25 mg wafers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability | Plasma concentrations collected for 10 hours after simultaneous wafer administration and sequential wafer administration | 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment related adverse events | 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. |
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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:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sam Salman, MD | iX Biopharma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear Clinical Research | Nedlands | Western Australia | 6009 | Australia |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 20 minutes |
| Administrator Acceptance | The person administering drug will rate their experience by completing a questionnaire 20 minutes after each dose. | 20 minutes |