Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
54
Countries
1
Sites
2
Renal impairment (mild, moderate and severe)
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 8 May 2024 → 23 Sep 2025
- Decision date (initial)
- 2024-02-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508557-13-00
- WHO UTN
- U1111-1298-3135
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Renal impairment (mild, moderate and severe)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.1 | PT | 10062237 | Renal impairment | 100000004857 |
| 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 · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 54 | 2 |
| 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 |
|---|---|---|---|---|---|
| Germany | 2024-05-08 | 2025-09-23 | 2024-05-15 | 2025-09-17 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-15 | Germany | Acceptable 2024-02-15
|
2024-02-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-20 | Germany | Acceptable 2024-07-09
|
2024-07-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-29 | Germany | Acceptable 2024-11-14
|
2024-11-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-20 | Germany | Acceptable 2025-01-14
|
2025-01-22 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-05-20 | Germany | Acceptable 2025-06-04
|
2025-06-04 |