Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
20
Countries
1
Sites
2
Celiac disease
Key facts
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 15 Mar 2024 → 9 Oct 2025
- Decision date (initial)
- 2023-10-19
- 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
Celiac disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10007864 | Celiac disease | 10017947 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Teva Branded Pharmaceutical Products R&D LLC
- Sponsor organisation
- Teva Branded Pharmaceutical Products R&D LLC
- 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 · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ended | 6 | 2 |
| Rest of world
United States, Australia
|
— | 14 | — |
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 |
|---|---|---|---|---|---|
| Finland | 2024-03-15 | 2025-10-08 | 2024-04-30 | 2024-06-14 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-07 | Finland | Acceptable 2023-10-17
|
2023-10-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-07 | Finland | Acceptable | 2024-01-16 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-01-19 | Finland | Acceptable | 2024-01-19 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-02-16 | Finland | Acceptable 2024-03-25
|
2024-03-26 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-04-16 | Finland | Acceptable 2024-03-25
|
2024-04-16 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-05-24 | Finland | Acceptable 2024-03-25
|
2024-05-24 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-02-27 | Finland | Acceptable 2024-03-25
|
2025-02-27 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-03-24 | Finland | Acceptable 2024-03-25
|
2025-03-24 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-06-02 | Finland | Acceptable 2024-03-25
|
2025-06-02 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-09-10 | Finland | Acceptable 2024-03-25
|
2025-09-10 |