Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
12
Countries
1
Sites
2
Solid tumors
Key facts
- Sponsor
- PTC Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Oct 2023 → 11 Jan 2024
- Decision date (initial)
- 2023-04-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502118-10-00
- WHO UTN
- U1111-1285-5565
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10049280 | Solid tumour | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
PTC Therapeutics Inc.
- Sponsor organisation
- PTC Therapeutics Inc.
- Address
- 100 Corporate Court
- City
- South Plainfield
- Postcode
- 07080-2400
- Country
- United States
Scientific contact point
- Organisation
- PTC Therapeutics Inc.
- Contact name
- Medical Information, PTC Therapeutics International Limited
Public contact point
- Organisation
- PTC Therapeutics Inc.
- Contact name
- Medical Information, PTC Therapeutics International Limited
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ended | 12 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Magyarorszag
PRA Klinikai Farmakológiai Vizsgálóhely, Rottenbiller Utca 13, 1077, Budapest
Central Hospital Of Northern Pest Military Hospital
Onkológiai Osztály, Podmaniczky Utca 109, 1062, Budapest VI
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 | 2023-10-27 | 2023-11-10 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-01-09 | Hungary | Acceptable 2023-04-14
|
2023-04-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-08-24 | Hungary | Acceptable 2023-09-28
|
2023-10-05 |