Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
7
Countries
1
Sites
1
Primary sclerosing cholangitis (PSC)
Key facts
- Sponsor
- Ipsen Pharma
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 18 Feb 2025 → 14 Apr 2025
- Decision date (initial)
- 2025-01-29
- 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
Primary sclerosing cholangitis (PSC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10036732 | Primary sclerosing cholangitis | 10019805 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ipsen Pharma
- Sponsor organisation
- Ipsen Pharma
- Address
- 65 Quai Georges Gorse
- City
- Boulogne Billancourt
- Postcode
- 92100
- Country
- France
Scientific contact point
- Organisation
- Ipsen Pharma
- Contact name
- Medical Development Director
Public contact point
- Organisation
- Ipsen Pharma
- Contact name
- Ipsen Clinical Study Enquiries
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 7 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharma Bio-Research Group
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2025-02-18 | 2025-04-14 | 2025-02-27 | 2025-03-12 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-16 | Netherlands | Acceptable 2025-01-29
|
2025-01-29 |