Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
54
Countries
1
Sites
1
N/A - healthy volunteers
Key facts
- Sponsor
- Bedrocan International B.V.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Psychological Phenomena [F02]
- Decision date (initial)
- 2024-02-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-505159-35-00
- WHO UTN
- U1111-1291-3321
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
N/A - healthy volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bedrocan International B.V.
- Sponsor organisation
- Bedrocan International B.V.
- Address
- De Zwaaikom 4
- City
- Veendam
- Postcode
- 9641 KV
- Country
- Netherlands
Scientific contact point
- Organisation
- Bedrocan International B.V.
- Contact name
- Clinical Trial Information Desk
Public contact point
- Organisation
- Bedrocan International B.V.
- Contact name
- Clinical Trial Information Desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 54 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Bedrocan International B.V.
Clinical Research Unit, De Zwaaikom 4, 9641 KV, Veendam
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-17 | Netherlands | Acceptable 2024-02-02
|
2024-02-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-25 | Netherlands | Acceptable 2024-08-26
|
2024-10-04 |