Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
36
Countries
1
Sites
1
Hypercholesterolemia
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 7 Jun 2024 → 3 Jan 2025
- Decision date (initial)
- 2024-06-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-510402-40-00
- WHO UTN
- U1111-1301-9068
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Hypercholesterolemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10020604 | Hypercholesterolemia | 10027433 |
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
- Kelly Duncan
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Kelly Duncan
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 | 2024-06-07 | 2025-01-02 | 2024-06-20 | 2025-01-02 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-22 | Belgium | Acceptable 2024-06-03
|
2024-06-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-07 | Belgium | Acceptable | 2024-06-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-29 | Belgium | Acceptable 2024-09-04
|
2024-09-04 |