Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Authorised, recruitment pending
Participants planned
24
Countries
1
Sites
1
Primary insomnia characterized by poor quality of sleep
Key facts
- Sponsor
- Pileje
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Decision date (initial)
- 2025-08-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Primary insomnia characterized by poor quality of sleep
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pileje
- Sponsor organisation
- Pileje
- Address
- 31-35 Rue De La Federation
- City
- Paris
- Postcode
- 75015
- Country
- France
Scientific contact point
- Organisation
- Pileje
- Contact name
- Clotilde LANGLOIS
Public contact point
- Organisation
- Pileje
- Contact name
- Clotilde LANGLOIS
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 24 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-17 | France | Acceptable 2025-08-28
|
2025-08-28 |