Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
56
Countries
1
Sites
3
Hot Flush
Key facts
- Sponsor
- Astellas Pharma Global Development Inc.
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12]
- Decision date (initial)
- 2026-04-03
- 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
Hot Flush
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10060800 | Hot flush | 100000004866 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Astellas Pharma Global Development Inc.
- Sponsor organisation
- Astellas Pharma Global Development Inc.
- Address
- 2375 Waterview Drive
- City
- Northbrook
- Postcode
- 60062-6145
- Country
- United States
Scientific contact point
- Organisation
- Astellas Pharma Global Development Inc.
- Contact name
- RA Clinical Trial Unit Head
Public contact point
- Organisation
- Astellas Pharma Global Development Inc.
- Contact name
- RA Clinical Trial Unit Head
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Authorised, recruitment pending | 56 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-24 | Bulgaria | Acceptable 2026-03-26
|
2026-04-03 |