Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
30
Countries
1
Sites
1
Healthy volunteers (Non-alcoholic steatohepatitis (NASH))
Key facts
- Sponsor
- Novo Nordisk A/S
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 14 Dec 2023 → 30 Dec 2024
- Decision date (initial)
- 2023-07-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503595-24-00
- WHO UTN
- U1111-1279-3843
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy volunteers (Non-alcoholic steatohepatitis (NASH))
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.0 | PT | 10053219 | Non-alcoholic steatohepatitis | 100000004871 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novo Nordisk A/S
- Sponsor organisation
- Novo Nordisk A/S
- Address
- Novo Alle 1
- City
- Bagsvaerd
- Postcode
- 2880
- Country
- Denmark
Scientific contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- EU Submission HUB
Public contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- EU Submission HUB
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 30 | 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 |
|---|---|---|---|---|---|
| Austria | 2023-12-14 | 2024-12-30 | 2023-12-18 | 2024-10-14 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-12 | Austria | Acceptable 2023-07-10
|
2023-07-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-07-28 | Austria | Acceptable 2023-09-11
|
2023-09-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-19 | Austria | Acceptable 2023-11-24
|
2023-12-11 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-03-01 | Austria | Acceptable 2023-11-24
|
2024-03-01 |