Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
30
Countries
1
Sites
1
Non-alcoholic steatohepatitis
Key facts
- Sponsor
- Inventiva
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 11 Feb 2026 → 26 May 2026
- Decision date (initial)
- 2026-02-04
- 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
Non-alcoholic steatohepatitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | LLT | 10086372 | NASH | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Inventiva
- Sponsor organisation
- Inventiva
- Address
- 50 Rue De Dijon
- City
- Daix
- Postcode
- 21121
- Country
- France
Scientific contact point
- Organisation
- Inventiva
- Contact name
- Medical Director
Public contact point
- Organisation
- Inventiva
- Contact name
- Medical Director
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | 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 |
|---|---|---|---|---|---|
| France | 2026-02-11 | 2026-05-26 | 2026-02-17 | 2026-05-10 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-21 | France | Acceptable 2026-02-04
|
2026-02-04 |