Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
24
Countries
1
Sites
1
Pain
Key facts
- Sponsor
- H. Lundbeck A/S
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Musculoskeletal and Neural Physiological Phenomena [G11]
- Trial duration
- 3 Oct 2023 → 17 May 2024
- Decision date (initial)
- 2023-09-13
- 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
Pain
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
H. Lundbeck A/S
- Sponsor organisation
- H. Lundbeck A/S
- Address
- Ottiliavej 9
- City
- Valby
- Postcode
- 2500
- Country
- Denmark
Scientific contact point
- Organisation
- H. Lundbeck A/S
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- H. Lundbeck A/S
- Contact name
- Clinical Trial Information
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 24 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre for Human Drug Research
Experimental Medicine, Zernikedreef 8, 2333 CL, Leiden
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 |
|---|---|---|---|---|---|
| Netherlands | 2023-10-03 | 2024-05-17 | 2023-10-13 | 2024-05-17 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-31 | Netherlands | Acceptable 2023-09-11
|
2023-09-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-17 | Netherlands | Acceptable | 2023-12-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-01-31 | Netherlands | Acceptable 2024-02-27
|
2024-02-27 |