Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
40
Countries
1
Sites
1
Post-bariatric hypoglycaemia
Key facts
- Sponsor
- Recordati AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 4 Nov 2025 → 3 Feb 2026
- Decision date (initial)
- 2025-07-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Post-bariatric hypoglycaemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10059035 | Postprandial hypoglycaemia | 100000004861 |
| 21.1 | PT | 10077216 | Hyperinsulinaemic hypoglycaemia | 100000004861 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Recordati AG
- Sponsor organisation
- Recordati AG
- Address
- Uferstrasse 90
- City
- Basel Town
- Postcode
- 4057
- Country
- Switzerland
Scientific contact point
- Organisation
- Recordati AG
- Contact name
- Arnd Mueller
Public contact point
- Organisation
- Recordati AG
- Contact name
- Recordati AG Clinical Trial Information Desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 40 | 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 |
|---|---|---|---|---|---|
| Germany | 2025-11-04 | 2026-02-03 | 2025-11-06 | 2026-01-14 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-30 | Germany | Acceptable 2025-07-01
|
2025-07-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-23 | Germany | Acceptable 2025-07-01
|
2025-12-23 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-01-13 | Germany | Acceptable 2025-07-01
|
2026-01-13 |