Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
80
Countries
1
Sites
1
HIV-1 infection
Key facts
- Sponsor
- Merck Sharp & Dohme LLC, Merck Sharp & Dohme LLC
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 20 Oct 2023 → 1 Jun 2024
- Decision date (initial)
- 2023-10-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506697-12-00
- WHO UTN
- U1111-1294-2739
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
HIV-1 infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10068341 | HIV-1 infection | 10021881 |
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
- Marian Iwamoto
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Marian Iwamoto
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 1 Merck Drive, P. O. Box 100 P. O. Box 100
- City
- Whitehouse Station
- Postcode
- 08889-3400
- Country
- United States
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 80 | 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 | 2023-10-20 | 2024-05-31 | 2023-10-23 | 2024-05-29 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-17 | Belgium | Acceptable 2023-09-28
|
2023-10-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-02 | Belgium | Acceptable | 2023-10-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-13 | Belgium | Acceptable | 2024-05-30 |