Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
56
Countries
1
Sites
1
atherothrombotic and thromboembolic disorders
Key facts
- Sponsor
- Janssen Cilag International
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 19 Mar 2024 → ongoing
- Decision date (initial)
- 2024-02-12
- 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
atherothrombotic and thromboembolic disorders
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 |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 56 | 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 |
|---|---|---|---|---|---|
| Belgium | 2024-03-19 | 2024-04-02 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-20 | Belgium | Acceptable 2024-02-06
|
2024-02-12 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-02-16 | Acceptable 2024-02-06
|
||
| 3 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-03-01 | Belgium | Acceptable | 2024-04-02 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-08-26 | Belgium | Acceptable | 2024-08-26 |
| 5 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-12-20 | Belgium | Acceptable 2025-01-21
|
2025-02-13 |
| 6 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-03-11 | Belgium | Acceptable 2025-03-27
|
2025-03-27 |