Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
72
Countries
1
Sites
1
Healthy volunteers
Key facts
- Sponsor
- GE Healthcare Limited
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 16 Aug 2023 → 25 Mar 2025
- Decision date (initial)
- 2023-07-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy volunteers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10019276 | Heart disease unspecified | 10007541 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
GE Healthcare Limited
- Sponsor organisation
- GE Healthcare Limited
- Address
- Pollards Wood, Nightingales Lane Nightingales Lane
- City
- Chalfont St. Giles
- Postcode
- HP8 4SP
- Country
- United Kingdom
Scientific contact point
- Organisation
- GE Healthcare Limited
- Contact name
- Jing Hao
Public contact point
- Organisation
- GE Healthcare Limited
- Contact name
- GE Healthcare
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 72 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 | 2023-08-16 | 2025-03-25 | 2023-08-16 | 2024-03-11 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-19 | Netherlands | Acceptable 2023-07-31
|
2023-07-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-20 | Netherlands | Acceptable 2024-02-05
|
2024-02-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-02-14 | Netherlands | Acceptable 2024-02-27
|
2024-02-27 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-03 | Netherlands | Acceptable 2024-02-27
|
2024-09-03 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-28 | Netherlands | Acceptable | 2024-12-12 |