Healthy volunteers
Conditions
Interventions
Drug administration of esketamine in OTF formulation.
Sponsors
Leiden University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: - aged 18-45 years, - body mass index > 19 and < 30 kg/m2, - able to understand the written informed consent form, - able to communicate with the staff, - able and willing to complete the study procedures, - signed the informed consent form, - deemed suitable by the investigators. - nonsmoking for the last 3 months.
Exclusion criteria
Exclusion criteria: - Presence or history of any medical or psychiatric disease (incl. a history of substance abuse, anxiety, or the presence of a painful syndrome); - Use of any medication in the three months prior to the study (incl. paracetamol or other pain killers); - Use of more than 21 alcohol units per week; - Use of illegal substances, including cannabis, in the 4 weeks prior to the study; - A positive urinary drug test or a breath alcohol test at screening or on the morning of the experiment; - Pregnancy, lactating or a positive pregnancy test on the morning of the experiment; - Participation in another drug trial in the 60 days prior to dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of S-ketamine and S-norketamine. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine safety and tolerability of the esketamine oral thin film. | — |
Contacts
Public ContactPieter Simons
LUMC
Outcome results
None listed