Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
36
Countries
3
Sites
4
Hepatic Impairment
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 24 Sep 2024 → 8 Oct 2025
- Decision date (initial)
- 2024-07-31
- 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
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
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Locations
3 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 8 | 1 |
| Poland | Ended | 6 | 1 |
| Slovakia | Ended | 22 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
CRS Clinical Research Services Management GmbH
Clinical Pharmacology Unit, Board of Managing Directors, Lornsenstrasse 7, Brunswik, Kiel
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
Centrum Badań Klinicznych Ośrodek Badań Wczesnej Fazy, Ul. Ul. Jana Dlugosza 4, 51-162, Wroclaw
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 |
|---|---|---|---|---|---|
| Germany | 2024-10-29 | 2025-10-07 | 2024-10-29 | 2025-09-09 | |
| Poland | 2024-10-07 | 2025-10-07 | 2024-10-07 | 2025-09-09 | |
| Slovakia | 2024-09-24 | 2025-09-16 | 2024-09-26 | 2025-09-09 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-07 | Germany | Acceptable 2024-07-29
|
2024-07-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-13 | Acceptable | 2025-01-10 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-13 | Germany | Acceptable | 2024-12-20 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-15 | Acceptable | 2025-02-21 |