Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
15
Countries
1
Sites
1
Nontuberculous mycobacterial disease
Key facts
- Sponsor
- Radboud universitair medisch centrum Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 22 Jun 2023 → 11 Jun 2025
- Decision date (initial)
- 2024-09-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517758-87-00
- EudraCT number
- 2019-000938-20
- ClinicalTrials.gov
- NCT05861258
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Nontuberculous mycobacterial disease
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Radboud universitair medisch centrum Stichting
- Sponsor organisation
- Radboud universitair medisch centrum Stichting
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Arthur Lemson
Public contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Arthur Lemson
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 15 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Radboud universitair medisch centrum Stichting
Pulmonary Diseased, 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 | 2023-06-22 | 2023-06-23 | 2025-05-09 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-06 | Netherlands | Acceptable with conditions 2024-09-24
|
2024-09-24 |