Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
48
Countries
1
Sites
1
Nonalcoholic fatty liver disease (NAFLD)
Key facts
- Sponsor
- Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 10 Oct 2023 → 17 Apr 2025
- Decision date (initial)
- 2023-10-06
- 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
Nonalcoholic fatty liver disease (NAFLD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.0 | LLT | 10029530 | Non-alcoholic fatty liver | 10019805 |
| 20.1 | LLT | 10036732 | Primary sclerosing cholangitis | 10019805 |
| 22.0 | PT | 10053219 | Non-alcoholic steatohepatitis | 100000004871 |
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
Dr. Falk Pharma GmbH
- Sponsor organisation
- Dr. Falk Pharma GmbH
- Address
- Leinenweberstrasse 5, Hochdorf Hochdorf
- City
- Freiburg Im Breisgau
- Postcode
- 79108
- Country
- Germany
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ended | 48 | 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 |
|---|---|---|---|---|---|
| Hungary | 2023-10-10 | 2025-04-17 | 2023-10-10 | 2025-03-13 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-05 | Hungary | Acceptable 2023-08-28
|
2023-10-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-12 | Hungary | Acceptable | 2024-03-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-16 | Hungary | Acceptable 2024-05-07
|
2024-05-13 |