Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
64
Countries
1
Sites
1
Narcolepsy
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 7 Jul 2023 → 30 Aug 2024
- Decision date (initial)
- 2023-07-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504954-37-00
- WHO UTN
- U1111-1290-4681
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Narcolepsy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10028713 | Narcolepsy | 100000004852 |
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
- Sarah Janicki Hsieh
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Sarah Janicki Hsieh
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 64 | 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 | 2023-07-07 | 2024-08-29 | 2023-07-10 | 2024-08-28 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-22 | Belgium | Acceptable 2023-07-03
|
2023-07-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-03 | Belgium | Acceptable 2023-12-11
|
2023-12-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-10 | Belgium | Acceptable 2024-05-15
|
2024-05-15 |