Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
225
Countries
2
Sites
2
Healthy volunteers
Key facts
- Sponsor
- Xentria Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 5 Jun 2024 → 23 Jul 2025
- Decision date (initial)
- 2024-06-04
- 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
Healthy volunteers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10031282 | Osteoporosis | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Xentria Inc.
- Sponsor organisation
- Xentria Inc.
- Address
- 2032 North Clybourn Avenue Suite 100
- City
- Chicago
- Postcode
- 60614-4051
- Country
- United States
Scientific contact point
- Organisation
- Xentria Inc.
- Contact name
- Tom Matthews
Public contact point
- Organisation
- Xentria Inc.
- Contact name
- Noopur Singh
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ended | 117 | 1 |
| Netherlands | Ended | 108 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Magyarorszag
PRA Klinikai Farmakológiai Vizsgálóhely, Rottenbiller Utca 13, 1077, Budapest
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 |
|---|---|---|---|---|---|
| Hungary | 2024-06-14 | 2025-07-22 | 2024-06-14 | 2024-11-12 | |
| Netherlands | 2024-06-05 | 2025-07-17 | 2024-06-05 | 2024-11-07 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-04 | Netherlands | Acceptable 2024-05-30
|
2024-05-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-23 | Netherlands | Acceptable 2024-09-02
|
2024-09-02 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-31 | Netherlands | Acceptable 2024-09-02
|
2024-10-31 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-13 | Netherlands | Acceptable 2025-07-21
|
2025-07-22 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-08-18 | Netherlands | Acceptable 2025-07-21
|
2025-08-18 |