Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
130
Countries
1
Sites
1
Movement disorders
Key facts
- Sponsor
- Neurocrine Biosciences Inc.
- 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
- 29 Mar 2024 → ongoing
- Decision date (initial)
- 2024-02-16
- 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
Movement disorders
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Neurocrine Biosciences Inc.
- Sponsor organisation
- Neurocrine Biosciences Inc.
- Address
- 6027 Edgewood Bend Court
- City
- San Diego
- Postcode
- 92130-8235
- Country
- United States
Scientific contact point
- Organisation
- Neurocrine Biosciences Inc.
- Contact name
- Neurocrine Medical Information Call Center
Public contact point
- Organisation
- Neurocrine Biosciences Inc.
- Contact name
- Neurocrine Medical Information Call Center
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 130 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre for Human Drug Research
Neurology, 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 | 2024-03-29 | 2024-04-16 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-11 | Netherlands | Acceptable 2024-02-16
|
2024-02-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-09 | Netherlands | Acceptable 2024-02-16
|
2024-04-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-17 | Netherlands | Acceptable 2024-07-29
|
2024-07-29 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-21 | Netherlands | Acceptable 2024-07-29
|
2024-10-21 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-11-25 | Netherlands | Acceptable 2024-07-29
|
2024-11-25 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-03-13 | Netherlands | Acceptable 2024-07-29
|
2025-03-13 |
| 7 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-20 | Netherlands | Acceptable 2025-06-03
|
2025-06-06 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-09-03 | Netherlands | Acceptable 2025-06-03
|
2025-09-03 |
| 9 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-28 | Netherlands | Acceptable 2025-12-19
|
2025-12-19 |