Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
103
Countries
1
Sites
1
Parkinson disease (PD)
Key facts
- Sponsor
- Institut De Recherches Internationales Servier IRIS
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 4 Oct 2022 → 14 Oct 2024
- Decision date (initial)
- 2024-11-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519381-53-00
- EudraCT number
- 2022-001526-30
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Parkinson disease (PD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10061536 | Parkinson's disease | 100000004852 |
| 20.0 | SOC | 10029205 | Nervous system disorders | 8 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut De Recherches Internationales Servier IRIS
- Sponsor organisation
- Institut De Recherches Internationales Servier IRIS
- Address
- 22 Route 128
- City
- Gif Sur Yvette
- Postcode
- 91190
- Country
- France
Scientific contact point
- Organisation
- Institut De Recherches Internationales Servier IRIS
- Contact name
- Clinical Studies Department
Public contact point
- Organisation
- Institut De Recherches Internationales Servier IRIS
- Contact name
- Clinical Studies Department
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 103 | 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 |
|---|---|---|---|---|---|
| France | 2022-10-04 | 2024-10-14 | 2022-10-04 | 2024-09-27 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-07 | France | Acceptable 2024-11-12
|
2024-11-13 |