Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
12
Countries
1
Sites
1
distal renal tubular acidosis (dRTA)
Key facts
- Sponsor
- Advicenne
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 25 Feb 2025 → 18 Mar 2025
- Decision date (initial)
- 2025-02-19
- 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
distal renal tubular acidosis (dRTA)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Advicenne
- Sponsor organisation
- Advicenne
- Address
- 262 Rue Du Faubourg Saint Honore
- City
- Paris
- Postcode
- 75008
- Country
- France
Scientific contact point
- Organisation
- Advicenne
- Contact name
- Didier Laurens, Chief Executive Officer
Public contact point
- Organisation
- Advicenne
- Contact name
- Didier Laurens, Chief Executive Officer
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 12 | 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 | 2025-02-25 | 2025-03-18 | 2025-02-25 | 2025-03-03 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-25 | France | Acceptable 2025-01-24
|
2025-02-19 |