Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
178
Countries
1
Sites
1
Narcolepsy
Key facts
- Sponsor
- Bioprojet Pharma
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 28 Oct 2025 → ongoing
- Decision date (initial)
- 2025-10-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Narcolepsy
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bioprojet Pharma
- Sponsor organisation
- Bioprojet Pharma
- Address
- 9 Rue Rameau
- City
- Paris
- Postcode
- 75002
- Country
- France
Scientific contact point
- Organisation
- Bioprojet Pharma
- Contact name
- Regulatory affairs director
Public contact point
- Organisation
- Bioprojet Pharma
- Contact name
- Regulatory affairs director
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 178 | 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 |
|---|---|---|---|---|---|
| Belgium | 2025-10-28 | 2025-10-28 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-03 | Belgium | Acceptable with conditions 2025-10-07
|
2025-10-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-13 | Belgium | Acceptable with conditions 2025-10-07
|
2025-10-13 |