Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
100
Countries
1
Sites
1
Healthy participants (part 1 and part 2)
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
- Trial duration
- 26 Oct 2023 → 17 Jul 2024
- Decision date (initial)
- 2023-10-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy participants (part 1 and part 2)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10041242 | Social anxiety disorder | 100000004873 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Head of CTRM , Clinical Trial Regulatory Management, Product Development Regulatory
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Head of CTRM , Clinical Trial Regulatory Management, Product Development Regulatory
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 100 | 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 | 2023-10-26 | 2024-07-17 | 2023-10-26 | 2024-07-17 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-13 | France | Acceptable 2023-10-16
|
2023-10-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-11 | France | Acceptable 2024-04-05
|
2024-04-09 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-28 | France | Acceptable 2024-04-05
|
2024-05-28 |