Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
20
Countries
1
Sites
1
Healthy Volunteers
Key facts
- Sponsor
- CHU De Rouen
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 19 Apr 2024 → ongoing
- Decision date (initial)
- 2023-10-16
- 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
Healthy Volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CHU De Rouen
- Sponsor organisation
- CHU De Rouen
- Address
- 1 Rue De Germont, Bp 96031 Bp 96031
- City
- Rouen Cedex
- Postcode
- 76031
- Country
- France
Scientific contact point
- Organisation
- CHU De Rouen
- Contact name
- Florian VALLIN
Public contact point
- Organisation
- CHU De Rouen
- Contact name
- Florian VALLIN
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
CHU De Rouen
Pharmacologie clinique, 1 Rue De Germont, Bp 96031, Rouen Cedex
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 |
|---|---|---|---|---|---|
| France | 2024-04-19 | 2024-04-26 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-30 | France | Acceptable 2023-10-05
|
2023-10-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-29 | France | Acceptable 2024-02-12
|
2024-02-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-03 | France | Acceptable 2025-10-08
|
2025-11-13 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-25 | France | Acceptable 2025-10-08
|
2025-11-25 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-11 | France | Acceptable 2025-10-08
|
2026-02-11 |