Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
26
Countries
1
Sites
1
Depression
To investigate the tolerability of a single dose of KET01 (240 mg) compared to intranasal esketamine (84 mg; active comparator) with respect to dissociative symptoms assessed by change in Clinician-Administered Dissociative States Scale (CADSS) total score in healthy male subjects.
Key facts
- Sponsor
- Ketabon GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 1 Jun 2023 → 7 Aug 2023
- Decision date (initial)
- 2023-05-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Pharmacokinetic, Safety
To investigate the tolerability of a single dose of KET01 (240 mg) compared to intranasal esketamine (84 mg; active comparator) with respect to dissociative symptoms assessed by change in Clinician-Administered Dissociative States Scale (CADSS) total score in healthy male subjects.
Conditions and MedDRA coding
Depression
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10057840 | Major depression | 100000004873 |
Regulatory references
| EU CT number | Title | Sponsor |
|---|---|---|
| 2021-004927-34 | A multicentre, double-blind, randomised, placebo-controlled phase II trial with a 3 week treatment period to assess the efficacy, safety and tolerability of add-on treatment with Ketamine hydrochloride prolonged release tablets (KET01, 120 mg or 240 mg once daily) in outpatients with treatment resistant depression, Wieloośrodkowe, podwójnie zaślepione, randomizowane, kontrolowane placebo badanie fazy II z trzytygodniowym okresem leczenia w celu oceny skuteczności, bezpieczeństwa i tolerancji leczenia dodanego z użyciem chlorowodorku ketaminy w postaci tabletek o przedłużonym uwalnianiu (KET01, 120mg lub 240 mg raz dziennie) u pacjentów ambulatoryjnych z lekooporną depresją |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Participant must be between ≥ 18 and ≤ 45 years of age at the time of signing the informed consent.
- Certified as healthy by a comprehensive clinical assessment (including detailed medical history)
- BMI between 18.5 and 30 kg/m2 (inclusive) and body weight ≥ 50 kg.
- Male
Exclusion criteria 7
- Anatomical or medical conditions that may impede delivery or absorption of study medication (e.g., undergone facial reconstruction, rhinoplasty, significant structural or functional abnormalities of the nose or upper airway (e.g. nasal piercing); obstructions or mucosal lesions of the nostrils or nasal passages; undergone sinus surgery in the previous 2 years; or signs and symptoms of rhinitis on days of IMP administration) or surgery in medical history which may have an impact on absorption as assessed by the investigator.
- Any previous administration or use of ketamine and esketamine (including known or suspected es-/ketamine-anesthesia), or other ketamine-related and/or dissociative drugs (e.g. phencyclidine [PCP]), Nitrous Oxide or dextromethorphan [at doses higher than the recommended therapeutic dose for cough suppression])
- History or presence of any clinically significant disease or disorder including (but not limited to) cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, respiratory/pulmonary, gastrointestinal, psychiatric, neurological, musculoskeletal, endocrine , metabolic, malignant or major physical impairment which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject’s ability to participate in the study.
- Subjects with first-degree relatives (parents, brothers, sisters or children) with psychotic or bipolar disorders.
- Family history of sudden cardiac death in first-degree relatives.
- History of alcohol use disorder or substance use disorder, including e.g. benzodiazepines, opiates, hallucinogens and related drugs, stimulants (e.g. 3,4-methylenedioxymethamphetamine [MDMA], amphetamines, cocaine) or cannabis, except nicotine and caffeine, or a positive drug abuse test.
- Hypertension (after 5 minutes of rest, systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg) at Visit 1.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Maximum change in CADSS Score from baseline to any time after IMP administration within the period.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Spravato 28 mg nasal spray, solution
PRD7778029 · Product
- Active substance
- Esketamine Hydrochloride
- Pharmaceutical form
- NASAL SPRAY, SOLUTION
- Route of administration
- NASAL SPRAY
- Max daily dose
- 84 mg milligram(s)
- Max total dose
- 168 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- N06AX27 — -
- Marketing authorisation
- EU/1/19/1410/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling and Repackaging
Ketamine hydrochloride prolonged release tablets
PRD10278228 · Product
- Active substance
- Ketamine Hydrochloride
- Pharmaceutical form
- PROLONGED RELEASE TABLETS
- Route of administration
- ORAL USE
- Max daily dose
- 240 mg milligram(s)
- Max total dose
- 480 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- KETABON GMBH
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 2
Placebo for Ketamine hydrochloride prolonged release tablet
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Placebo for Spravato, nasal spray
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ketabon GmbH
- Sponsor organisation
- Ketabon GmbH
- Address
- Wilhelm-Wagenfeld-Strasse 20, Schwabing-Freimann Schwabing-Freimann
- City
- Munich
- Postcode
- 80807
- Country
- Germany
Scientific contact point
- Organisation
- Ketabon GmbH
- Contact name
- Clinical Trial Information Point
Public contact point
- Organisation
- Ketabon GmbH
- Contact name
- Clinical Trial Information Point
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Scope International AG ORG-100009715
|
Mannheim, Germany | Code 8 |
| ACC GmbH Analytical Clinical Concepts ORG-100015425
|
Leidersbach, Germany | Laboratory analysis |
| Charite Research Organisation GmbH ORG-100028160
|
Berlin, Germany | On site monitoring, Code 11, Code 12, Code 5, Data management |
| Myonex GmbH ORG-100043534
|
Berlin, Germany | Code 14 |
| GCP-Service International Limited & Co. KG ORG-100036955
|
Bremen, Germany | Code 10 |
| SGS Analytics Germany GmbH ORG-100013017
|
Berlin, Germany | Laboratory analysis |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 26 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2023-06-01 | 2023-08-07 | 2023-06-01 | 2023-08-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of Results SUM-38268
|
2024-08-01T08:11:25 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Layperson summary of results | 2024-08-01T08:14:48 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | 240725_LaySummary_v1_KET01-03 | 1 |
| Summary of results (for publication) | 240709_CSR Synopsis_v1_KET01-03 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-06 | Germany | Acceptable 2023-05-17
|
2023-05-19 |