Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
60
Countries
1
Sites
1
Healthy volunteer trial
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Not possible to specify
- Trial duration
- 30 Apr 2024 → 29 Apr 2025
- Decision date (initial)
- 2024-02-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506722-36-00
- WHO UTN
- U1111-1298-0452
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy volunteer trial
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | LLT | 10088820 | Clinical trial healthy volunteer | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 60 | 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 | 2024-04-30 | 2025-04-29 | 2024-05-06 | 2024-10-11 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-04 | Belgium | Acceptable 2024-02-26
|
2024-02-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-01 | Belgium | Acceptable | 2024-03-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-11 | Belgium | Acceptable 2024-04-25
|
2024-04-25 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-10 | Belgium | Acceptable 2024-07-18
|
2024-07-31 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-16 | Belgium | Acceptable with conditions 2025-01-31
|
2025-01-31 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-20 | Belgium | Acceptable 2025-03-11
|
2025-03-12 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-04-15 | Belgium | Acceptable 2025-05-05
|
2025-05-06 |