Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
24
Countries
1
Sites
1
Pain
Key facts
- Sponsor
- Biohaven Therapeutics Ltd.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 7 Oct 2024 → 11 Dec 2024
- Decision date (initial)
- 2024-08-20
- 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
Pain
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Biohaven Therapeutics Ltd.
- Sponsor organisation
- Biohaven Therapeutics Ltd.
- Address
- 215 Church Street
- City
- New Haven
- Postcode
- 06510-1803
- Country
- United States
Scientific contact point
- Organisation
- Biohaven Therapeutics Ltd.
- Contact name
- Research and Development Medical Director
Public contact point
- Organisation
- Biohaven Therapeutics Ltd.
- Contact name
- Chief Compliance Officer
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 24 | 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 |
|---|---|---|---|---|---|
| Germany | 2024-10-07 | 2024-12-10 | 2024-10-07 | 2024-10-22 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-25 | Germany | Acceptable 2024-08-14
|
2024-08-20 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-24 | Germany | Acceptable 2024-08-14
|
2024-10-24 |