Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
32
Countries
1
Sites
2
Volunteers with Hepatic Impairment
Key facts
- Sponsor
- Amylyx Pharmaceuticals EMEA B.V., Amylyx Pharmaceuticals Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 31 Oct 2023 → 20 Mar 2024
- Decision date (initial)
- 2023-08-23
- 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
Volunteers with Hepatic Impairment
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10019670 | Hepatic function abnormal | 100000004871 |
| 20.0 | HLT | 10019661 | Hepatic enzymes and function abnormalities | 10019805 |
| 20.0 | SOC | 10019805 | Hepatobiliary disorders | 15 |
| 22.1 | LLT | 10052254 | Hepatic impairment | 10019805 |
| 20.0 | HLGT | 10019654 | Hepatic and hepatobiliary disorders | 10019805 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amylyx Pharmaceuticals EMEA B.V.
- Sponsor organisation
- Amylyx Pharmaceuticals EMEA B.V.
- Address
- Barbara Strozzilaan 201
- City
- Amsterdam
- Postcode
- 1083 HN
- Country
- Netherlands
Scientific contact point
- Organisation
- Amylyx Pharmaceuticals EMEA B.V.
- Contact name
- Medical Information
Public contact point
- Organisation
- Amylyx Pharmaceuticals EMEA B.V.
- Contact name
- Medical Information
Amylyx Pharmaceuticals Inc.
- Sponsor organisation
- Amylyx Pharmaceuticals Inc.
- Address
- 43 Thorndike Street
- City
- Cambridge
- Postcode
- 02141-1764
- Country
- United States
Scientific contact point
- Organisation
- Amylyx Pharmaceuticals Inc.
- Contact name
- Medical Information
Public contact point
- Organisation
- Amylyx Pharmaceuticals Inc.
- Contact name
- Medical Information
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 32 | 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 | 2023-10-31 | 2024-03-20 | 2023-11-08 | 2024-02-07 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-16 | Bulgaria | No conclusion 2023-07-31
|
2023-08-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-10-27 | Bulgaria | No conclusion 2023-07-31
|
2023-10-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-30 | Bulgaria | No conclusion | 2024-02-05 |