Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
25
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
- 12 Dec 2023 → 7 Feb 2024
- Decision date (initial)
- 2023-11-10
- 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
Healthy volunteer trial
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10053349 | Pharmacokinetic study | 10022891 |
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 |
|---|---|---|---|
| Netherlands | Ended | 25 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2023-12-12 | 2024-02-07 | 2023-12-18 | 2024-01-18 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-02 | Netherlands | Acceptable 2023-11-10
|
2023-11-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-11-30 | Netherlands | Acceptable 2023-11-10
|
2023-11-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-30 | Netherlands | Acceptable 2023-12-14
|
2023-12-14 |