Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
96
Countries
1
Sites
1
Parkinson's Disease
Key facts
- Sponsor
- Arvinas Operations Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Phenomena and Processes [G] - Musculoskeletal and Neural Physiological Phenomena [G11]
- Trial duration
- 4 Jan 2024 → 13 Feb 2025
- Decision date (initial)
- 2023-12-21
- 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
Parkinson's Disease
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Arvinas Operations Inc.
- Sponsor organisation
- Arvinas Operations Inc.
- Address
- 5 Science Park
- City
- New Haven
- Postcode
- 06511-1966
- Country
- United States
Scientific contact point
- Organisation
- Arvinas Operations Inc.
- Contact name
- Juan Chavez
Public contact point
- Organisation
- Arvinas Operations Inc.
- Contact name
- Stefanie Doty
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 96 | 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 | 2024-01-04 | 2025-02-13 | 2024-01-10 | 2025-02-13 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-13 | Netherlands | Acceptable 2023-12-21
|
2023-12-21 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-01-29 | Netherlands | Acceptable 2023-12-21
|
2024-01-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-03 | Netherlands | Acceptable 2024-05-22
|
2024-05-22 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-07-19 | Netherlands | Acceptable 2024-05-22
|
2024-07-19 |