Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
60
Countries
1
Sites
1
Clostridioides difficile (C. difficile)
Key facts
- Sponsor
- Idorsia Pharmaceuticals Ltd.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 28 May 2024 → 19 Mar 2026
- Decision date (initial)
- 2024-04-16
- 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
Clostridioides difficile (C. difficile)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10054236 | Clostridium difficile infection | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Idorsia Pharmaceuticals Ltd.
- Sponsor organisation
- Idorsia Pharmaceuticals Ltd.
- Address
- Hegenheimermattweg 91
- City
- Allschwil
- Postcode
- 4123
- Country
- Switzerland
Scientific contact point
- Organisation
- Idorsia Pharmaceuticals Ltd.
- Contact name
- Idorsia Clinical Trials Information
Public contact point
- Organisation
- Idorsia Pharmaceuticals Ltd.
- Contact name
- Idorsia Clinical Trials Information
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 | 2024-05-28 | 2026-03-19 | 2024-07-01 | 2025-10-27 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-06 | Germany | Acceptable 2024-04-12
|
2024-04-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-17 | Germany | Acceptable 2025-08-12
|
2025-08-20 |