Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
82
Countries
1
Sites
1
Apathy in neurodegenerative disorders
Key facts
- Sponsor
- Integrative Research Laboratories Sweden AB
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 16 May 2024 → 7 Feb 2025
- Decision date (initial)
- 2024-05-03
- 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
Apathy in neurodegenerative disorders
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10002942 | Apathy | 100000004873 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Integrative Research Laboratories Sweden AB
- Sponsor organisation
- Integrative Research Laboratories Sweden AB
- Address
- Arvid Wallgrens Backe 20, Goteborgs Annedal Goteborgs Annedal
- City
- Goteborg
- Postcode
- 413 46
- Country
- Sweden
Scientific contact point
- Organisation
- Integrative Research Laboratories Sweden AB
- Contact name
- Chief Medical Officer
Public contact point
- Organisation
- Integrative Research Laboratories Sweden AB
- Contact name
- Chief Medical Officer
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 82 | 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 |
|---|---|---|---|---|---|
| Sweden | 2024-05-16 | 2025-02-07 | 2024-05-16 | 2025-01-20 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-16 | Sweden | Acceptable 2024-05-03
|
2024-05-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-14 | Sweden | Acceptable 2024-12-11
|
2024-12-11 |