Phase I Trial: Quotient Code QSC301409

ISRCTN	ISRCTN12857535
DOI	https://doi.org/10.1186/ISRCTN12857535
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	1011685
Protocol serial number	QSC301409
Sponsor	Shionogi B.V.
Funder	Shionogi B.V.

Submission date: 13/08/2025
Registration date: 20/08/2025
Last edited: 20/08/2025

Recruitment status: No longer 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 Nand Singh
Principal investigator

Quotient Sciences Limited
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom

Phone	+44 (0) 330 303 1000
Email	recruitment@weneedyou.co.uk

Dr Regulatory Affairs Department
Public, Scientific

Shionogi B.V., Herengracht 464
Amsterdam
1017 CA
Netherlands

Phone	+44 (0)20 3053 4200
Email	regulatory.affairs@shionogi.eu

Study information

Primary study design	Interventional
Study design	Absorption metabolism distribution and elimination (ADME) study
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Phase I Trial: Quotient Code QSC301409
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 19/08/2025, London - Surrey Borders Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, United Kingdom; +44 (0)20 7972 8143; surreyborders.rec@hra.nhs.uk), ref: 25/LO/0338
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	15/10/2025

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	30 Years
Upper age limit	65 Years
Sex	Male
Target sample size at registration	10
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	05/09/2025
Date of final enrolment	15/10/2025

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Quotient Sciences Limited

Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
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 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

13/08/2025: Trial's existence confirmed by MHRA.