Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
20
Countries
1
Sites
1
healthy breastfeeding women
Key facts
- Sponsor
- Stichting Radboud University Medical Center
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 1 Oct 2024 → 28 Apr 2025
- Decision date (initial)
- 2024-09-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-510232-36-00
- EudraCT number
- 2022-003715-29
- ClinicalTrials.gov
- NCT05648201
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
healthy breastfeeding women
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10020161 | HIV infection | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stichting Radboud University Medical Center
- Sponsor organisation
- Stichting Radboud University Medical Center
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Stichting Radboud University Medical Center
- Contact name
- Wendy van der Wekken
Public contact point
- Organisation
- Stichting Radboud University Medical Center
- Contact name
- Wendy van der Wekken
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Radboud universitair medisch centrum Stichting
Pharmacy, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-10-01 | 2025-04-28 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-29 | Netherlands | Acceptable with conditions 2024-09-12
|
2024-09-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-08 | Netherlands | Acceptable 2025-07-03
|
2025-07-03 |