Overview
Sponsor-declared trial summary
healthy volunteers
• Part 1 Effect of esketamine on the sustained hypoxic ventilatory response with hypoxia lasting 25 min. • Part 2 Reversal of remifentanil-induced depression of the acute hypoxic ventilatory response by esketamine with hypoxia lasting 2 times 7 min (once at low and once at high CO2 levels)
Key facts
- Sponsor
- Leiden University Medical Center
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Physiological processes [G07]
- Trial duration
- 4 Aug 2023 → 14 Mar 2025
- Decision date (initial)
- 2023-06-12
- 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: Pharmacodynamic
• Part 1 Effect of esketamine on the sustained hypoxic ventilatory response with hypoxia lasting 25 min.
• Part 2 Reversal of remifentanil-induced depression of the acute hypoxic ventilatory response by esketamine with hypoxia lasting 2 times 7 min (once at low and once at high CO2 levels)
Secondary objectives 2
- Psychomimetic side effects at the end of a hypoxic episode.
- Esketamine plasma concentrations
Conditions and MedDRA coding
healthy volunteers
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- aged 18-45 years
- • Body mass index 19-30 kg/m2;
- • Able to read and understand the subject information.
Exclusion criteria 9
- • A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •• A history of clinically significant (as deemed by the investigators) medical or psychiatric disease. These include: clinically significant illness or disease (e.g., psychiatric disorders, disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or any clinically significant abnormal symptom or organ impairment, as judged by the investigator, found by medical history, physical examinations or vital signs at screening;
- • any allergy to food or medication;
- • weekly alcohol intake of more than 3 units/day or more than 21 units/week in women and 5 units/day and 35 units/week in men;
- • pregnancy or lactation;
- • women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative urine pregnancy test prior to enrolment and must agree to use a medically acceptable means of contraception from screening through at least 1 month after the last dose of study drug. By contraception we mean for women: intrauterine device (IUD), diaphragm with spermicide, oral contraceptive, injectable progesterone, subdermal implant or a tubal ligation. Males who are sexually active and whose partners are females of childbearing potential must agree to use condoms.
- • participation in an investigational drug trial in the 3 months before the current study;
- • illicit drug use in the 30 days before the current study;
- • a positive drug urine dipstick on the screening or study days.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Hypoxic ventilatory response
Secondary endpoints 2
- Psychomimetic side effects at the end of a hypoxic episode.
- Esketamine plasma concentrations
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Ketanest-S® 5, oplossing voor injectie 5 mg/ml
PRD6796180 · Product
- Active substance
- Esketamine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AX14 — ESKETAMINE
- Marketing authorisation
- RVG 22550
- MA holder
- PFIZER B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Remifentanil-hameln 1 mg, poeder voor concentraat voor oplossing voor injectie of infusie
PRD8934385 · Product
- Active substance
- Remifentanil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AH06 — REMIFENTANIL
- Marketing authorisation
- RVG 103427
- MA holder
- HAMELN PHARMA GMBH
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
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
Auxiliary 1
Naloxon Orpha 0,4 mg/ml, oplossing voor injectie of infusie
PRD308843 · Product
- Active substance
- Naloxone Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AB15 — NALOXONE
- Marketing authorisation
- RVG 30938
- MA holder
- ORPHA-DEVEL HANDELS UND VERTRIEBS GMBH
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Leiden University Medical Center
- Sponsor organisation
- Leiden University Medical Center
- Address
- Albinusdreef 2
- City
- Leiden
- Postcode
- 2333 ZA
- Country
- Netherlands
Scientific contact point
- Organisation
- Leiden University Medical Center
- Contact name
- Albert Dahan
Public contact point
- Organisation
- Leiden University Medical Center
- Contact name
- Albert Dahan
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 18 | 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 |
|---|---|---|---|---|---|
| Netherlands | 2023-08-04 | 2025-03-14 | 2023-08-22 |
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-97495
|
2025-09-12T08:14:58 | Submitted | Summary of Results |
Documents 1 file
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Summary of results (for publication) | HEOE results | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-07 | Netherlands | Acceptable 2023-06-12
|
2023-06-12 |