Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
8
Countries
1
Sites
1
Healthy participant
Key facts
- Sponsor
- Teva Branded Pharmaceutical Products R&D Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 7 Oct 2024 → 29 Nov 2024
- Decision date (initial)
- 2024-10-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy participant
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10064060 | Multiple system atrophy | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Teva Branded Pharmaceutical Products R&D Inc.
- Sponsor organisation
- Teva Branded Pharmaceutical Products R&D Inc.
- Address
- 145 Brandywine Parkway
- City
- West Chester
- Postcode
- 19380-4245
- Country
- United States
Scientific contact point
- Organisation
- Teva Branded Pharmaceutical Products R&D Inc.
- Contact name
- Medical Information
Public contact point
- Organisation
- Teva Branded Pharmaceutical Products R&D Inc.
- Contact name
- Medical Information
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 8 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 | 2024-10-07 | 2024-11-29 | 2024-10-08 | 2024-10-15 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-19 | Netherlands | Acceptable 2024-10-04
|
2024-10-04 |