Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
16
Countries
1
Sites
1
Nonalcoholic fatty liver disease
Key facts
- Sponsor
- CCDRD Cooperative Clinical Drug Research and Development AG, Galmed Research And Development Ltd.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 18 Dec 2024 → 12 Jun 2025
- Decision date (initial)
- 2024-12-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-507445-28-00
- ClinicalTrials.gov
- NCT06502561
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Nonalcoholic fatty liver disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.1 | PT | 10053219 | Non-alcoholic steatohepatitis | 100000004871 |
| 25.0 | LLT | 10082249 | Nonalcoholic fatty liver disease | 100000004871 |
| 20.1 | LLT | 10036732 | Primary sclerosing cholangitis | 10019805 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CCDRD Cooperative Clinical Drug Research and Development AG
- Sponsor organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Address
- Lindenallee 70, Dahlwitz-Hoppegarten Dahlwitz-Hoppegarten
- City
- Hoppegarten
- Postcode
- 15366
- Country
- Germany
Scientific contact point
- Organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Contact name
- Sacha Arsova
Public contact point
- Organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Contact name
- Sacha Arsova
Galmed Research And Development Ltd.
- Sponsor organisation
- Galmed Research And Development Ltd.
- Address
- 16 Tiomkin
- City
- Tel Aviv-Yafo
- Postcode
- 6578317
- Country
- Israel
Scientific contact point
- Organisation
- Galmed Research And Development Ltd.
- Contact name
- Yossi Gilgun-Sherki
Public contact point
- Organisation
- Galmed Research And Development Ltd.
- Contact name
- Yossi Gilgun-Sherki
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 16 | 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 |
|---|---|---|---|---|---|
| Bulgaria | 2024-12-18 | 2025-06-12 | 2024-12-18 | 2025-05-21 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-09 | Bulgaria | Acceptable 2024-12-09
|
2024-12-13 |