Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
32
Countries
1
Sites
2
Tuberculosis
Key facts
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization Inc.
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 13 Nov 2025 → 13 Mar 2026
- Decision date (initial)
- 2025-09-19
- 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
Tuberculosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10044755 | Tuberculosis | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Otsuka Pharmaceutical Development & Commercialization Inc.
- Sponsor organisation
- Otsuka Pharmaceutical Development & Commercialization Inc.
- Address
- 2440 Research Boulevard
- City
- Rockville
- Postcode
- 20850-3238
- Country
- United States
Scientific contact point
- Organisation
- Otsuka Pharmaceutical Development & Commercialization Inc.
- Contact name
- EU Clinical Trials Helpdesk
Public contact point
- Organisation
- Otsuka Pharmaceutical Development & Commercialization Inc.
- Contact name
- EU Clinical Trials Helpdesk
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 | 2025-11-13 | 2026-03-12 | 2025-11-13 | 2026-03-12 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-16 | Bulgaria | Acceptable 2025-09-15
|
2025-09-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-20 | Bulgaria | Acceptable 2025-09-15
|
2025-10-20 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-01-19 | Bulgaria | Acceptable 2025-09-15
|
2026-01-19 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-03-05 | Bulgaria | Acceptable 2025-09-15
|
2026-03-05 |