Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
44
Countries
1
Sites
1
Non-alcoholic steatohepatitis
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 9 Feb 2024 → 27 Jun 2024
- Decision date (initial)
- 2024-02-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508982-34-00
- WHO UTN
- U1111-1299-2628
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-alcoholic steatohepatitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.1 | PT | 10053219 | Non-alcoholic steatohepatitis | 100000004871 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Mickie Cheng
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Mickie Cheng
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 44 | 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 |
|---|---|---|---|---|---|
| Belgium | 2024-02-09 | 2024-06-26 | 2024-02-13 | 2024-05-31 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-12 | Belgium | Acceptable 2024-01-29
|
2024-02-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-01 | Belgium | Acceptable 2024-03-18
|
2024-03-21 |