Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
24
Countries
2
Sites
3
Participants with normal hepatic function
Key facts
- Sponsor
- Italfarmaco S.p.A.
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 16 May 2025 → 14 Aug 2025
- Decision date (initial)
- 2025-04-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513577-43-00
- ClinicalTrials.gov
- NCT06736223
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Participants with normal hepatic function
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.1 | LLT | 10052254 | Hepatic impairment | 10019805 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Italfarmaco S.p.A.
- Sponsor organisation
- Italfarmaco S.p.A.
- Address
- Via Dei Lavoratori 54
- City
- Cinisello Balsamo
- Postcode
- 20092
- Country
- Italy
Scientific contact point
- Organisation
- Italfarmaco S.p.A.
- Contact name
- Paolo Tornese
Public contact point
- Organisation
- Italfarmaco S.p.A.
- Contact name
- Patient advocacy department
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 16 | 2 |
| France | Ended | 8 | 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 |
|---|---|---|---|---|---|
| Bulgaria | 2025-05-16 | 2025-08-11 | 2025-05-29 | 2025-07-30 | |
| France | 2025-06-10 | 2025-08-14 | 2025-07-21 | 2025-07-29 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-27 | France | Acceptable 2025-04-10
|
2025-04-30 |