Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
20
Countries
1
Sites
2
This study is a phase I trial, a single-dose, open label, randomized, two-period, two-sequence, crossover bioavailability study comparing IV to oral Dofetilide.
Key facts
- Sponsor
- Hyloris Developments
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 22 Jul 2024 → 4 Nov 2024
- Decision date (initial)
- 2024-07-03
- 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
This study is a phase I trial, a single-dose, open label, randomized, two-period, two-sequence, crossover bioavailability study comparing IV to oral Dofetilide.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10003663 | Atrial flutter/ fibrillation | 10007541 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hyloris Developments
- Sponsor organisation
- Hyloris Developments
- Address
- Boulev. De Patience Et Beajonc 3 Bus 1
- City
- Liege
- Postcode
- 4000
- Country
- Belgium
Scientific contact point
- Organisation
- Hyloris Developments
- Contact name
- Christophe Lyssens
Public contact point
- Organisation
- Hyloris Developments
- Contact name
- Christophe Lyssens
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 20 | 2 |
| 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 |
|---|---|---|---|---|---|
| Bulgaria | 2024-07-22 | 2024-11-04 | 2024-07-23 | 2024-10-09 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-22 | Bulgaria | Acceptable 2024-07-03
|
2024-07-03 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-02 | Bulgaria | Acceptable 2024-07-03
|
2024-10-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-03 | Bulgaria | Acceptable | 2024-10-28 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-11-01 | Bulgaria | Acceptable | 2024-11-01 |