None listed
Conditions
Brief summary
Participants will be admitted to the research clinical for three separate inpatient periods, each period separated by a minimum of 3 days. Participants will check in the afternoon before planned dosing and will stay inpatient for 24 hours after study medication for each inpatient period. In one period, a single dose of intravenous ketamine 10 mg will be administered and in the two other periods a single 25 mg ketamine wafer (two different formulations) will be administered under the tongue. No food or drink except water is allowed starting 10 hours before each study medication dose and for 4 hours after dosing. Water is restricted 1 hour before and after dosing.
Interventions
Participants will complete three inpatient periods, each period separated by a minimum of 3 days. Participants will be admitted the afternoon before and will remain inpatient until 24 hours after each study medication dose. Two formulations of Wafermine Trademark sublingual ketamine wafers will be tested, Formulation A and Formulation B. The wafers contain identical pharmaceutical contents. The difference between the wafers is the freeze-drying method of manufacture. During one session, a si
Participants will complete three inpatient periods, each period separated by a minimum of 3 days. Participants will be admitted the afternoon before and will remain inpatient until 24 hours after each study medication dose. Two formulations of Wafermine Trademark sublingual ketamine wafers will be tested, Formulation A and Formulation B. The wafers contain identical pharmaceutical contents. The difference between the wafers is the freeze-drying method of manufacture. During one session, a single dose of Wafermine Trademark (ketamine wafer) Formulation A 25 mg will be administered under the tongue. During another session, a single dose of Wafermine Trademark (ketamine wafer) Formulation B 25 mg will be administered under the tongue. During another session, Ketalar Registered Trademark (intravenous ketamine) 10 mg will be administered over 5 minutes. No food or drink except water is allowed for at least 10 hours before the study medication dose. Water is restricted 1 hour before and after dosing.
Sponsors
iX Biopharma Ltd.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the Principal Investigator. 2. Have suitable venous access for blood sampling. 3. Females must be non-pregnant, non-lactating, and using an acceptable form of birth control. 4. BMI within the range of 19.0-30.0 kg/m2 (inclusive). 5. Deemed able to read and understand English in order to communicate with research staff and complete protocol required questionnaires and forms.
Exclusion criteria
1. Has abnormal, clinically significant laboratory value at the Screening Visit (including positive serology results for Hepatitis B or C or HIV). . 2. Any gastrointestinal condition, which could affect drug absorption. 3. History of clinically significant condition involving the bladder or urinary tract, including frequent urinary tract infections (e.g. greater than 2 per year), or current symptoms of bladder irritation such as frequent or urgent need to urinate or burning with urination. 4. History (within the last six months) of or current clinically significant psychiatric disorder including anxiety, psychosis or depression. 5. Current inflammatory or ulcerative disease of the oral cavity that could impair the absorption of sublingual medication. 6. History of severe allergic or anaphylactic drug-related reactions. 7. History of hypersensitivity to ketamine or any of the excipients of Wafermine Trademark. 8. Intake of any Over-The-Counter (OTC)/non-prescribed drugs including vitamins, minerals, supplements or herbal medicines within 1 week of Period 1 study drug administration, or intake of prescribed drugs within 2 weeks of Period 1 study drug administration. 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, or any drug known to be a strong inhibitor of CYP3A4 within 5 half-lives of treatment period 1 and throughout the study. 9. Participation in another clinical trial of an investigational agent within 30 days of study entry. 10. Clinically significant, as determined by the Investigator, abnormal ECG (12-lead) or vital signs at the screening visit or pre-dose (Day 1). 11. Drug (including analgesic drugs or tranquilizers) or alcohol abuse or dependence.
Outcome results
None listed