Phase I Trial: Sponsor code: X11-201-00001

ISRCTN	ISRCTN50440735
DOI	https://doi.org/10.1186/ISRCTN50440735
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	1009721
Protocol serial number	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: 31/03/2025

Recruitment status: Recruiting
Overall study status: Deferred
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Ashley Brooks
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
Email	ashleybrooks@macplc.com

Dr Neel Bhatt
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
Email	neelbhatt@macplc.com

Study information

Primary study design	Interventional
Study design	Phase 1a/b Randomized double blinded placebo controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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	10/06/2026

Eligibility

Participant type(s)	Other
Age group	Adult
Sex	All
Target sample size at registration	72
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	27/03/2025
Date of final enrolment	11/06/2026

Locations

Countries of recruitment

United Kingdom

Study participating centres

MAC Clinical Research, Early Phase Unit

Neuroscience Centre of Excellence Citilabs1.0, Nelson Street
Manchester, Greater Manchester
M13 9NQ
United Kingdom

MAC Clinical Research Centre

11 Tiger Court, King's Drive King's Business Park
Prescot, Merseyside
L34 1BH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available because of their high commercial sensitivity and the negligible benefit to the public of publication of results of non-therapeutic clinical trials.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

31/03/2025: Trial's existence confirmed by MHRA.