Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
20
Countries
1
Sites
1
obesity
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Toulouse
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 9 Apr 2024 → ongoing
- Decision date (initial)
- 2022-08-12
- 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
obesity
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Toulouse
- Sponsor organisation
- Centre Hospitalier Universitaire De Toulouse
- Address
- Cedex 9, 2 Rue Viguerie 2 Rue Viguerie
- City
- Toulouse
- Postcode
- 31300
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Toulouse
- Contact name
- clinical research assistant (sponsor)
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Toulouse
- Contact name
- clinical research assistant (sponsor)
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
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 | 2024-04-09 | 2024-04-09 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-06-15 | France | Acceptable 2022-08-12
|
2022-08-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-07-07 | France | Acceptable 2023-08-11
|
2023-08-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-01-18 | France | Acceptable 2024-02-29
|
2024-03-13 |