Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
60
Countries
3
Sites
3
Idiopathic or diabetic gastroparesis
Key facts
- Sponsor
- Dr. Falk Pharma GmbH
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 16 Jul 2025 → ongoing
- Decision date (initial)
- 2025-08-26
- 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
Idiopathic or diabetic gastroparesis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10021227 | Idiopathic gastroparesis | 10017947 |
| 20.0 | LLT | 10018043 | Gastroparesis | 10017947 |
| 20.1 | PT | 10051153 | Diabetic gastroparesis | 100000004856 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Dr. Falk Pharma GmbH
- Sponsor organisation
- Dr. Falk Pharma GmbH
- Address
- Leinenweberstrasse 5, Hochdorf Hochdorf
- City
- Freiburg Im Breisgau
- Postcode
- 79108
- Country
- Germany
Scientific contact point
- Organisation
- Dr. Falk Pharma GmbH
- Contact name
- CTIS – Scientific Request
Public contact point
- Organisation
- Dr. Falk Pharma GmbH
- Contact name
- Clinical Research and Development
Locations
3 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 10 | 1 |
| Germany | Ongoing, recruiting | 24 | 1 |
| Poland | Ongoing, recruiting | 26 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
SocraTec R&D Concepts in Drug Research and Development GmbH
CPU, Mainzerhofplatz 14, Erfurt-Altstadt, Erfurt
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 | 2025-10-09 | 2025-12-17 | |||
| Germany | 2025-07-16 | 2025-08-25 | |||
| Poland | 2025-10-01 | 2025-11-03 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-12 | Germany | Acceptable 2025-04-17
|
2025-04-25 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-04 | Germany | Acceptable 2025-04-17
|
2025-06-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-05 | Germany | Acceptable | 2025-06-30 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-07-03 | Acceptable 2025-04-17
|
2025-08-26 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2025-07-04 | Acceptable 2025-04-17
|
2025-09-27 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-19 | Germany | Acceptable 2026-02-27
|
2026-03-02 |