Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
32
Countries
1
Sites
1
Hepatic impairment.
Key facts
- Sponsor
- Salix Pharmaceuticals Inc.
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 13 Nov 2023 → 25 May 2024
- Decision date (initial)
- 2023-10-13
- 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
Hepatic impairment.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.1 | LLT | 10052254 | Hepatic impairment | 10019805 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Salix Pharmaceuticals Inc.
- Sponsor organisation
- Salix Pharmaceuticals Inc.
- Address
- 400 Somerset Corporate Boulevard
- City
- Bridgewater
- Postcode
- 08807-2867
- Country
- United States
Scientific contact point
- Organisation
- Salix Pharmaceuticals Inc.
- Contact name
- Bausch Health
Public contact point
- Organisation
- Salix Pharmaceuticals Inc.
- Contact name
- Bausch Health
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ended | 18 | 1 |
| Rest of world
United States
|
— | 14 | — |
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 |
|---|---|---|---|---|---|
| Hungary | 2023-11-13 | 2024-05-24 | 2023-11-13 | 2024-05-24 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-13 | Hungary | Acceptable 2023-10-04
|
2023-10-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-17 | Hungary | Acceptable 2023-10-04
|
2024-04-17 |