Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
19
Countries
1
Sites
1
Not applicable - healthy volunteer trial
Key facts
- Sponsor
- Idorsia Pharmaceuticals Ltd.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 6 Jan 2025 → 22 Feb 2025
- Decision date (initial)
- 2024-12-10
- 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 - healthy volunteer trial
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 |
|---|---|---|---|
| Czechia | Ended | 19 | 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 | 2025-01-06 | 2025-02-21 | 2025-01-06 | 2025-01-18 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-25 | Czechia | Acceptable 2024-12-06
|
2024-12-10 |