Overview
Sponsor-declared trial summary
UDCA causes a reduction in cholesterol saturation of the bile by inhibiting cholesterol absorption in the intestine and reducing cholesterol secretion into the bile. Presumably, cholesterol gallstones are gradually dissolved by dispersion of the cholesterol and formation of liquid crystals.
Key facts
- Sponsor
- Cepha s.r.o., PRO.MED.CS Praha a.s.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 20 Feb 2025 → 14 Apr 2025
- Decision date (initial)
- 2025-02-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
UDCA causes a reduction in cholesterol saturation of the bile by inhibiting cholesterol absorption in the intestine and reducing cholesterol secretion into the bile. Presumably, cholesterol gallstones are gradually dissolved by dispersion of the cholesterol and formation of liquid crystals.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10017650 | Gallstones | 10019805 |
| 20.1 | LLT | 10004671 | Biliary sludge | 10019805 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cepha s.r.o.
- Sponsor organisation
- Cepha s.r.o.
- Address
- Komenskeho 19, Severni Predmesti Severni Predmesti
- City
- Plzen 1
- Postcode
- 323 00
- Country
- Czechia
Scientific contact point
- Organisation
- Cepha s.r.o.
- Contact name
- Clinical
Public contact point
- Organisation
- Cepha s.r.o.
- Contact name
- Clinical
PRO.MED.CS Praha a.s.
- Sponsor organisation
- PRO.MED.CS Praha a.s.
- Address
- Telcska 377/1, Michle Michle
- City
- Prague
- Postcode
- 140 00
- Country
- Czechia
Scientific contact point
- Organisation
- PRO.MED.CS Praha a.s.
- Contact name
- Jan Sixta
Public contact point
- Organisation
- PRO.MED.CS Praha a.s.
- Contact name
- Jan Sixta
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 24 | 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 |
|---|---|---|---|---|---|
| Czechia | 2025-02-20 | 2025-04-14 | 2025-02-20 | 2025-02-27 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-07 | Czechia | Acceptable 2025-02-12
|
2025-02-12 |