Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
240
Countries
1
Sites
1
No medical conditions or diseases will be examined, only healthy volunteers will participate.
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Trial duration
- 2 Sep 2024 → ongoing
- Decision date (initial)
- 2024-09-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515961-33-00
- EudraCT number
- 2016-004000-61
- ClinicalTrials.gov
- NCT03289949
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
No medical conditions or diseases will be examined, only healthy volunteers will participate.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.0 | SOC | 10022891 | Investigations | 23 |
| 22.1 | PT | 10061944 | Brain scan normal | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Gitte Moos Knudsen
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Gitte Moos Knudsen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 240 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Rigshospitalet
Neurobiology Research Unit, Blegdamsvej 9, 2100, Copenhagen Oe
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 |
|---|---|---|---|---|---|
| Denmark | 2024-09-02 | 2024-09-02 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-13 | Denmark | Acceptable 2024-09-02
|
2024-09-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-28 | Denmark | Acceptable 2025-12-12
|
2025-12-12 |