Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
48
Countries
1
Sites
1
Pruritus
Key facts
- Sponsor
- Teva Branded Pharmaceutical Products R&D Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 5 Mar 2024 → 22 Nov 2024
- Decision date (initial)
- 2024-02-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Pruritus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.1 | PT | 10037087 | Pruritus | 100000004858 |
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 |
|---|---|---|---|
| Denmark | Ended | 48 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Denmark | 2024-03-05 | 2024-11-22 | 2024-03-18 | 2024-09-20 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-23 | Denmark | Acceptable 2024-02-22
|
2024-02-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-05 | Denmark | Acceptable 2024-02-22
|
2024-03-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-07 | Denmark | Acceptable | 2024-05-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-12 | Denmark | Acceptable 2024-07-31
|
2024-08-06 |