Overview
Sponsor-declared trial summary
none, healthy subjects
The objective is to explore the ventilatory pattern of volunteers during and following administration of fentanyl.
Key facts
- Sponsor
- Academisch Ziekenhuis Leiden
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 4 Mar 2024 → 26 Apr 2024
- Decision date (initial)
- 2024-01-15
- 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: Safety, Efficacy, Pharmacodynamic, Pharmacokinetic
The objective is to explore the ventilatory pattern of volunteers during and following administration of fentanyl.
Secondary objectives 2
- Determine the occurrence of respiratory events.
- The comparison of gas values obtained from different sites
Conditions and MedDRA coding
none, healthy subjects
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Aged 18-45 years with body mass index 19-30 kg/m2
Exclusion criteria 5
- Currently meet the criteria for diagnosis of moderate or severe substance use disorder according to the DSM-5 criteria on any substances other than caffeine, or nicotine-
- Any active medical condition, organ disease or concurrent medication or treatment that may either compromise subject safety or interfere with study endpoints;
- Pregnancy or lactation;
- A positive drug urine dipstick on the screening or study days.
- History or presence of allergic response to study medication;
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Arterial PCO2 in the recovery phase of the study (i.e. the last 90 min of the study)
Secondary endpoints 2
- Respiratory events are defined by: 1) Respiratory rate ≤5 breaths/min for ≥3 min; 2) Oxygen saturation ≤ 85% for ≥ 3 min; 3) End-tidal PCO2 ≤ 2 kPa or ≥ 8 kPa for ≥ 3 min; 4) or apnea for at least 30 s; 5) any other respiratory event.
- Arterial versus venous versus end-tidal PCO2 at regular intervals
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Fentanyl hameln 50 microgram/ml, oplossing voor injectie
PRD3238668 · Product
- Active substance
- Fentanyl Citrate
- Substance synonyms
- FENTANYL DIHYDROGEN CITRATE, 2-HYDROXYPROPANE-1,2,3-TRICARBOXYLIC ACID, N-(1-PHENETHYL-4-PIPERIDYL)-N-PHENYL-PROPANAMIDE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 4 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AH01 — FENTANYL
- Marketing authorisation
- RVG 25458
- MA holder
- HAMELN PHARMA GMBH
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
Naloxone 400 micrograms/ml solution for injection/infusion
PRD10902978 · Product
- Active substance
- Naloxone Hydrochloride
- Substance synonyms
- N-ALLYLNOROXYMORPHONE HYDROCHLORIDE
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 90 mg milligram(s)
- Max total dose
- 180 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AB15 — NALOXONE
- Marketing authorisation
- PL 01502/0141
- MA holder
- HAMELN PHARMA LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Academisch Ziekenhuis Leiden
- Sponsor organisation
- Academisch Ziekenhuis Leiden
- Address
- Albinusdreef 2
- City
- Leiden
- Postcode
- 2333 ZA
- Country
- Netherlands
Scientific contact point
- Organisation
- Academisch Ziekenhuis Leiden
- Contact name
- Monique van Velzen
Public contact point
- Organisation
- Academisch Ziekenhuis Leiden
- Contact name
- Monique van Velzen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 12 | 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 | 2024-03-04 | 2024-04-26 | 2024-03-06 |
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 |
|---|---|---|---|
| FAME results SUM-97498
|
2025-09-12T08:19:48 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay person summary of results | 2025-12-05T08:54:05 | 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) | Lay person summary of results | 1 |
| Summary of results (for publication) | FAME results | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-24 | Netherlands | Acceptable 2024-01-15
|
2024-01-15 |