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Esketamine Oral Thin Film (OTF) administration * a pharmacokinetic pharmacodynamic study in healthy participants

Esketamine Oral Thin Film (OTF) administration * a pharmacokinetic pharmacodynamic study in healthy participants - ESKOT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51122
Enrollment
20
Registered
2020-11-18
Start date
2021-01-27
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pijnbehandeling neuropathic pain pain PK/PD

Interventions

Administration of S-ketamine mucosal patch (50 mg and 100 mg)

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - aged 18-45 years, - body mass index > 19 and

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

MeasureTime frame
-Plasma concentrations eskatemine and esnorketamine; -Antinociceptive responses to pressure pain, electrical pain and heat pain.

Secondary

MeasureTime frame
Response to Bowdle and Bond & Lader questionnaires.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)