Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
36
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
- 3 Aug 2023 → 28 Mar 2024
- Decision date (initial)
- 2023-07-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-505138-88-00
- WHO UTN
- U1111-1291-0977
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-alcoholic steatohepatitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.0 | 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
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Makeda Robinson
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Makeda Robinson
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 36 | 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 | 2023-08-03 | 2024-03-27 | 2023-08-08 | 2024-03-15 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-16 | Belgium | Acceptable 2023-07-19
|
2023-07-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-08-14 | Belgium | Acceptable 2023-07-19
|
2023-08-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-23 | Belgium | Acceptable 2024-01-18
|
2024-01-18 |