Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
44
Countries
1
Sites
1
Healthy Adult Participants
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 4 Aug 2023 → 22 Jan 2025
- Decision date (initial)
- 2023-06-30
- 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 Adult Participants
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen - Cilag International
- Sponsor organisation
- Janssen - Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 32 | 1 |
| Rest of world
United States
|
— | 12 | — |
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 |
|---|---|---|---|---|---|
| Germany | 2023-08-04 | 2024-08-13 | 2023-08-23 | 2024-08-13 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-18 | Germany | Acceptable 2023-06-19
|
2023-06-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-16 | Germany | Acceptable | 2023-08-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-01 | Germany | Acceptable 2023-12-21
|
2023-12-22 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-03-04 | Germany | Acceptable 2024-04-03
|
2024-04-05 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-12 | Germany | Acceptable 2024-07-26
|
2024-07-30 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-11 | Germany | Acceptable 2024-07-26
|
2024-09-11 |