Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
41
Countries
2
Sites
3
Hepatic impairment.
Key facts
- Sponsor
- Takeda Development Center Americas Inc.
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 5 Oct 2023 → 4 Sep 2025
- Decision date (initial)
- 2023-09-07
- 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
Hepatic impairment.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.1 | LLT | 10052254 | Hepatic impairment | 10019805 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Takeda Development Center Americas Inc.
- Sponsor organisation
- Takeda Development Center Americas Inc.
- Address
- 500 Kendall Street
- City
- Cambridge
- Postcode
- 02142-1108
- Country
- United States
Scientific contact point
- Organisation
- Takeda Development Center Americas Inc.
- Contact name
- Nirav Desai
Public contact point
- Organisation
- Takeda Development Center Americas Inc.
- Contact name
- Takeda
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ended | 22 | 1 |
| Slovakia | Ended | 19 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Summit Clinical Research s.r.o.
NA, Bardosova 2a, 831 01, Nove Mesto
Summit Clinical Research s.r.o.
NA, Duklianskych Hrdinov 34, 901 01, Malacky
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 |
|---|---|---|---|---|---|
| Hungary | 2023-10-05 | 2025-06-16 | 2023-10-05 | 2025-03-15 | |
| Slovakia | 2023-10-17 | 2025-09-03 | 2023-10-17 | 2025-03-15 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-15 | Hungary | Acceptable 2023-09-01
|
2023-09-04 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-11-17 | Hungary | Acceptable 2023-09-01
|
2023-11-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-12 | Hungary | Acceptable 2024-05-22
|
2024-05-22 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-06-11 | Hungary | Acceptable 2024-05-22
|
2024-06-11 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-06-12 | Hungary | Acceptable 2024-05-22
|
2024-06-12 |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-08 | Hungary | Acceptable 2024-08-03
|
2024-08-03 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-21 | Hungary | Acceptable 2025-02-03
|
2025-02-03 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-05-09 | Hungary | Acceptable 2025-02-03
|
2025-05-09 |