Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
60
Countries
1
Sites
1
Not applicable
Key facts
- Sponsor
- Ipsen Pharma
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 8 Nov 2024 → 11 Mar 2025
- Decision date (initial)
- 2024-10-10
- 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
Not applicable
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
- Peter Åkerblad
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 |
|---|---|---|---|
| Germany | Ended | 60 | 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 |
|---|---|---|---|---|---|
| Germany | 2024-11-08 | 2025-03-11 | 2024-11-08 | 2025-02-18 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-01 | Germany | Acceptable 2024-10-07
|
2024-10-10 |