Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
28
Countries
2
Sites
3
moderate or severe hepatic impairment
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 5 Jun 2023 → 23 Feb 2024
- Decision date (initial)
- 2023-05-25
- 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
moderate or severe 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
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Information Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Information Center
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 7 | 2 |
| Slovakia | Ended | 7 | 1 |
| Rest of world
United States
|
— | 14 | — |
Investigational sites
Medical Center COMAC Medical EOOD
NA, 3, Sv. Georgi Sofiyski Str., Sofia
Medical Center Comac Medical Ltd.
NA, Triaditsa, Ulitsa Urvich 13, Sofiya
Summit Clinical Research s.r.o.
Zariadenie biomedicínskeho výskumu (vnútorné lekárstvo, klinická farmakológia), Bardosova 2a, 831 01, Nove Mesto
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 |
|---|---|---|---|---|---|
| Bulgaria | 2023-07-27 | 2024-02-22 | 2023-08-24 | 2024-02-19 | |
| Slovakia | 2023-06-05 | 2024-02-22 | 2023-06-29 | 2024-02-19 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-01-27 | Slovakia | Acceptable 2023-05-19
|
2023-05-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-04 | Acceptable | 2023-10-23 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-12-22 | Slovakia | Acceptable | 2023-12-22 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-01-23 | Acceptable | 2024-01-23 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-01-29 | Slovakia | Acceptable 2024-03-18
|
2024-03-18 |