We hypothesize that esketamine in OTF formulation will produce plasma Sketamine and S-norketamine concentrations that are associated with adequate antinociception.
ID
Bron
Verkorte titel
Aandoening
Healthy volunteers
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Plasma concentrations of S-ketamine and S-norketamine.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
We hypothesize that esketamine in OTF formulation will produce plasma Sketamine
and S-norketamine concentrations that are associated with adequate antinociception.
Onderzoeksopzet
Screening, visit 1, visit 2.
Onderzoeksproduct en/of interventie
Drug administration of esketamine in OTF formulation.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9267 |
| Ander register | METC LDD : P20.111 |