Overview
Sponsor-declared trial summary
Recreational use while driving a vehicle. Healthy volunteers.
To determine the pharmacokinetic elimination rates of nitrous oxide from the body as measured in blood samples following short recreational intake.
Key facts
- Sponsor
- Koebenhavns Universitet
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 19 May 2024 → 21 Feb 2025
- Decision date (initial)
- 2024-03-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-509993-49-00
- WHO UTN
- U1111-1301-1099
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic
To determine the pharmacokinetic elimination rates of nitrous oxide from the body as measured in blood samples following short recreational intake.
Secondary objectives 1
- To determine the impact of short recreational intake of nitrous oxide on driving performance.
Conditions and MedDRA coding
Recreational use while driving a vehicle. Healthy volunteers.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Age ≥ 18 years
- Holder of a Danish driving license for ≥ 1 year
- Have ≥ 200 km of driving experience during the last year
- Informed consent
- Ability to read and understand Danish
Exclusion criteria 6
- No visible signs of injuries or conditions that might hinder the use of inhalation device
- No known medical history or diagnose contra-indicated for the use of the IMP
- Positive pregnancy test (females only)
- Failed eyesight tests
- No major simulator sickness after training
- Self-reported history of addictive behavior or a former/current regular recreational use of nitrous oxide
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- the blood concentration curve for nitrous oxide following the imitated recreational intake of nitrous oxide
Secondary endpoints 1
- the driving ability before, during and after imitated recreational intake of nitrous oxide, measured on a medium-fidelity driving simulator
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Kalinox, medicinsk gas, komprimeret
PRD405260 · Product
- Active substance
- Nitrous Oxide
- Pharmaceutical form
- MEDICINAL GAS, COMPRESSED
- Route of administration
- INHALATION GAS
- Max daily dose
- 10 min minute
- Max total dose
- 10 min minute
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AX63 — -
- Marketing authorisation
- 49418
- MA holder
- AIR LIQUIDE SANTE INTERNATIONAL
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
Medicinsk Oxygen “Strandmøllen”, medicinsk gas, komprimeret
PRD327583 · Product
- Active substance
- Oxygen
- Pharmaceutical form
- MEDICINAL GAS, COMPRESSED
- Route of administration
- INHALATION GAS
- Max daily dose
- 6 h hour
- Max total dose
- 6 h hour
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AN01 — -
- Marketing authorisation
- 42674
- MA holder
- STRANDMØLLEN A/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Koebenhavns Universitet
- Sponsor organisation
- Koebenhavns Universitet
- Address
- Frederik V's Vej 11
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Koebenhavns Universitet
- Contact name
- Brian Schou Rasmussen
Public contact point
- Organisation
- Koebenhavns Universitet
- Contact name
- Brian Schou Rasmussen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | 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 |
|---|---|---|---|---|---|
| Denmark | 2024-05-19 | 2025-02-21 | 2024-06-17 | 2024-08-30 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-13 | Denmark | Acceptable 2024-03-22
|
2024-03-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-09 | Denmark | Acceptable 2024-04-22
|
2024-05-23 |