Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
8
Countries
1
Sites
1
Not applicable - Healthy volonteers
Key facts
- Sponsor
- Structure Therapeutics Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Trial duration
- 24 Jun 2024 → 9 Sep 2024
- Decision date (initial)
- 2024-06-14
- 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
Not applicable - Healthy volonteers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10014697 | Endocrine disorder NOS | 10014698 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Structure Therapeutics Inc.
- Sponsor organisation
- Structure Therapeutics Inc.
- Address
- 601 Gateway Boulevard
- City
- South San Francisco
- Postcode
- 94080-7006
- Country
- United States
Scientific contact point
- Organisation
- Structure Therapeutics Inc.
- Contact name
- Eric Meltzer
Public contact point
- Organisation
- Structure Therapeutics Inc.
- Contact name
- Eric Meltzer
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 8 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-06-24 | 2024-09-09 | 2024-06-24 | 2024-07-05 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-22 | Netherlands | Acceptable 2024-06-14
|
2024-06-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-17 | Netherlands | Acceptable 2024-07-02
|
2024-07-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-10 | Netherlands | Acceptable 2024-10-01
|
2024-10-01 |