Phase I Trial: Quotient Code QSC300687

ISRCTN	ISRCTN31420409
DOI	https://doi.org/10.1186/ISRCTN31420409
IRAS number	1008711
Secondary identifying numbers	IRAS 1008711, Quotient Code: QSC300687

Submission date: 28/05/2024
Registration date: 31/05/2024
Last edited: 21/06/2024

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

Mere Way, Ruddington
Nottingham
NG11 6JS
United Kingdom

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

Ms Kavita Dhamdhere
Public, Scientific

15440 Laguna Canyon Road, Suite 160
Irvine
CA 92618
United States of America

Ms Alisa Hewitt
Public, Scientific

15440 Laguna Canyon Road, Suite 160
Irvine
CA 92618
United States of America

Study information

Study design	Mass balance recovery pharmacokinetic metabolite profiling and identification and safety and tolerability study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Pharmaceutical testing facility
Study type	Other
Participant information sheet	No participant information sheet available
Scientific title	Phase I Trial: Quotient Code QSC300687
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)	Submitted 30/04/2024, London - Surrey Borders REC (Equinox House, City Link, Nottingham, NG2 4LA, United Kingdom; + 44 (0) 20 7104 8057; surreyborders.rec@hra.nhs.uk), ref: 24/LO/0231
Health condition(s) or problem(s) studied	Healthy volunteers
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
Pharmaceutical study type(s)	Not Applicable
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	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.
Secondary outcome measures	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.
Overall study start date	30/04/2024
Completion date	18/01/2025

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Male
Target number of participants	8
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	02/07/2024
Date of final enrolment	18/01/2025

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Quotient Sciences Limited

Mere Way, Ruddington
Nottingham
NG11 6JS
United Kingdom

Sponsor information

Tarsus Pharmaceuticals, Inc.
Industry

15440 Laguna Canyon Road, Suite 160
Irvine
CA 92618
United States of America

Phone	+1 949 409 9820
Email	kdhamdhere@tarsusrx.com

Funders

Funder type

Industry

Tarsus Pharmaceuticals, Inc.

No information available

Results and Publications

Intention to publish date	18/07/2027
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Full trial details will be published up to 30 months after the end of the trial. Publication of some trial details is deferred because of the high commercial sensitivity of this phase I study and the negligible benefit to the public of phase I information. Results will be posted on or after the date of publication of full trial details.
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.

Editorial Notes

21/06/2024: A scientific/public contact was added.
28/05/2024: Trial's existence confirmed by MHRA