No registrations found.
ID
Source
Brief title
Health condition
Healthy volunteers
Sponsors and support
Intervention
Outcome measures
Primary outcome
Plasma concentrations of S-ketamine and S-norketamine.
Secondary outcome
To determine safety and tolerability of the esketamine oral thin film.
Background summary
The N-methyl-D-aspartate receptor antagonist ketamine is a potent anesthetic,
analgesic and antidepressant, increasingly used at subanesthetic doses to treat differentforms of pain, as well as depression. Currently the intravenous route is the predominant form of ketamine delivery with inherent need for a successful, sterile venipuncture by skilled healthcare personnel. This prevents the use of ketamine in the out-hospital setting, particularly in case of acute pain treatment (e.g., breakthrough pain). In the current study we will perform a pharmacokinetic-pharmacodynamic study on the efficacy of an esketamine oral thin film (OTF) using a cross-over design.
Study objective
We hypothesize that esketamine in OTF formulation will produce plasma Sketamine
and S-norketamine concentrations that are associated with adequate antinociception.
Study design
Screening, visit 1, visit 2.
Intervention
Drug administration of esketamine in OTF formulation.
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
- 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
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9267 |
| Other | METC LDD : P20.111 |