Phase I Trial: Sponsor code: X11-201-00001
| ISRCTN | ISRCTN50440735 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50440735 |
| Integrated Research Application System (IRAS) | 1009721 |
| Sponsor code | X11-201-00001 |
| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Funder | Otsuka Pharmaceutical Development & Commercialization, Inc. |
- Submission date
- 28/03/2025
- Registration date
- 31/03/2025
- Last edited
- 21/05/2026
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Other
Plain English summary of protocol
The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Contact information
Principal investigator
MAC Clinical Research , Early Phase Suite Neuroscience Centre of Excellence Citilabs 1.0, Nelson Street
Manchester
M13, 9NQ
United Kingdom
| Phone | +44 (0) 161 274 1603 |
|---|---|
| ashleybrooks@macplc.com |
Public, Scientific
MAC Clinical Research Centre 11 Tiger Court King's Drive King's Business Park Prescot
Merseyside
L34 1BH
United Kingdom
| Phone | +44 (0) 151 482 4700 |
|---|---|
| neelbhatt@macplc.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase Ia/b randomised double-blind placebo-controlled study |
| Secondary study design | Randomised controlled trial |
| Scientific title | Phase I Trial: Sponsor code: X11-201-00001 |
| Study objectives | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Ethics approval(s) |
Approved 11/03/2025, Wales Research Ethics Committee 1 Cardiff (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 2922940912; wales.rec1@wales.nhs.uk), ref: 25/WA/0026 |
| Health condition(s) or problem(s) studied | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Intervention | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Primary outcome measure(s) |
The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Key secondary outcome measure(s) |
The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Completion date | 07/05/2026 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 72 |
| Total final enrolment | 42 |
| Key inclusion criteria | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Key exclusion criteria | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Date of first enrolment | 31/03/2025 |
| Date of final enrolment | 06/05/2026 |
Locations
Countries of recruitment
- United Kingdom
Study participating centres
Manchester, Greater Manchester
M13 9NQ
England
Prescot, Merseyside
L34 1BH
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
21/05/2026: Otsuka has made a business decision to early terminate the trial. This decision is not based on safety reasons. The completion date was changed from 06/05/2026 to 07/05/2026. Final enrolment number added.
05/05/2026: The following changes were made to the study record:
1. Recruitment suspended.
2. The completion date was changed from 10/06/2026 to 06/05/2026.
3. The date of first enrolment was changed from 27/03/2025 to 31/03/2025.
4. The date of final enrolment was changed from 11/06/2026 to 06/05/2026.
31/03/2025: Trial's existence confirmed by MHRA.
