Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
20
Countries
1
Sites
1
Pulmonary Arterial Hypertension
Key facts
- Sponsor
- Actelion Pharmaceuticals Ltd.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 1 Apr 2025 → 19 Mar 2026
- Decision date (initial)
- 2025-01-13
- 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
Pulmonary Arterial Hypertension
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10064911 | Pulmonary arterial hypertension | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Actelion Pharmaceuticals Ltd.
- Sponsor organisation
- Actelion Pharmaceuticals Ltd.
- Address
- Gewerbestrasse 16
- City
- Allschwil
- Postcode
- 4123
- Country
- Switzerland
Scientific contact point
- Organisation
- Actelion Pharmaceuticals Ltd.
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Actelion Pharmaceuticals Ltd.
- Contact name
- CTIS Point of Contact
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire Rouen
Service de pharmacologie clinique, 1 Rue De Germont, Bp 96031, Rouen Cedex
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 | 2025-04-01 | 2026-03-19 | 2025-04-01 | 2026-01-23 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-30 | France | Acceptable 2024-11-05
|
2025-01-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-28 | France | Acceptable 2024-11-05
|
2025-01-28 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-29 | France | Acceptable 2025-02-25
|
2025-02-25 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-05 | France | Acceptable | 2025-04-15 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-11 | France | Acceptable 2025-09-15
|
2025-10-02 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-01-12 | France | Acceptable 2026-02-04
|
2026-02-04 |