Clinical trial • Phase III | Phase IV • Psychiatry

Esketamine hydrochloride for Healthy volunteers

Phase III | Phase IV trial of Esketamine hydrochloride for Healthy volunteers.

Overview

Trial Therapeutic Area
Psychiatry
Trial Disease
Healthy volunteers
Trial Stage
Phase III | Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
30-11-2024
First CTIS Authorization Date
30-01-2025

Trial design

Saline Solution Basi 9 mg/ml solution for infusion (placebo), intravenous infusion; product listing indicates maxDailyDoseAmount 500 ml (product used as placebo).-controlled Phase III | Phase IV trial across 1 site in Austria.

Comparator
Saline Solution Basi 9 mg/ml solution for infusion (placebo), intravenous infusion; product listing indicates maxDailyDoseAmount 500 ml (product used as placebo).
Target Sample Size
75
Trial Duration For Participant
1

Eligibility

Recruits 75 No vulnerable population selected; participants are adults (18-55 years). Written informed consent is required from each participant (participant provides their own consent). No assent procedures specified; subject information and informed consent form for adults available..

Pregnancy Exclusion
- Pregnancy or current breastfeeding
Vulnerable Population
No vulnerable population selected; participants are adults (18-55 years). Written informed consent is required from each participant (participant provides their own consent). No assent procedures specified; subject information and informed consent form for adults available.

Inclusion criteria

  • {"criterion_text":"- General health based on medical history, physical examination and structured clinical interview for DSM-IV (SCID)\n- Age 18 to 55 years\n- Right-handedness (due to potential lateralization effects of left- handed subjects)\n- Willingness and competence to sign the informed consent form"}

Exclusion criteria

  • {"criterion_text":"- Current or history of psychiatric or neurological disease\n- Current medical illness requiring treatment\n- Pregnancy or current breastfeeding\n- Current or former substance abuse\n- Diagnosis of an Axis-1 psychotic disorder in a first-degree relative\n- Any contraindication for MRI (e.g., MR incompatible implants, etc.) including dental implants causing signal artifacts\n- For subjects participating in earlier studies using ionizing radiation, the total radiation exposure of 30mSv over the last 10 years must not be exceeded, as specified in the Austrian legislation on radiation protection (Med. Strahlenschutzverordnung 11.01.2011; www.ris.bka.gv.at). Accordingly, body weight >100kg is an exclusion criterion (5.1 MBq/kg * 100kg * 0.019 mSv/Mbq * 0.885 = 8.58mSv per scan, the factor 0.885 is considered due to continuous radioligand infusion, see PET scanning).\n- Failure to comply with the study protocol or to follow the instruction of the investigating team."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- regional cerebral metabolic rate of glucose (rCMRGlu)\n- cerebral blood flow (CBF)\n- functional connectivity (FC)\n- Volumen (GMV)\n- mean diffusivity (MD)\n- fractional anisotropy (FA)","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Psychopathological effects of administration of the study medication","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
75
Recruitment Window Months
13
Consent Approach
Written informed consent obtained from each participant; participants (adults 18-55) provide their own consent. Subject information and informed consent form for adults (L1_SIS and ICF adults) available. Languages of consent documents not specified.

Geography

Total Number Of Sites
1
Total Number Of Participants
75

Austria

Earliest CTIS Part Ii Submission Date
27-12-2024
Latest Decision Or Authorization Date
30-01-2025
Processing Time Days
34
Number Of Sites
1
Number Of Participants
75

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Psychiatry and Psychotherapy, Division of General Psychiatry
Contact Person Name
Leo Silberbauer
Number Of Participants
75

Sponsor

Primary sponsor

Full Name
Medical University Of Vienna
Organisation Type
Educational Institution
Country Of Registered Address
Austria

Investigational products

Investigational Product Name
Ketanest® S 25 mg/ml - Ampullen
Active Substance
Esketamine hydrochloride
Modality
Small molecule
Routes Of Administration
Intravenous administration
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation number 1-22525, AT)
Maximum Dose
0.25 mg/kg
Investigational Product Name
Ketamin-hameln 50 mg/ml Injektionslösung
Active Substance
Ketamine hydrochloride
Modality
Small molecule
Routes Of Administration
Intravenous administration
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation number 32265.00.00, DE)
Maximum Dose
0.5 mg/kg
Investigational Product Name
Saline Solution Basi 9 mg/ml solution for infusion
Active Substance
Sodium chloride
Modality
Small molecule
Routes Of Administration
Intravenous administration
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation number 5211800, MT)
Maximum Dose
500 ml

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