ISRCTN ISRCTN90651766
DOI https://doi.org/10.1186/ISRCTN90651766
IRAS number 1009723
Secondary identifying numbers IRAS 1009723, Quotient code: QSC301813
Submission date
31/07/2024
Registration date
02/08/2024
Last edited
25/09/2024
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 Sharan Sidhu
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 Clinical Trials
Public, Scientific

Building 1
Grenzacherstrasse 124
Basel
CH-4070
Switzerland

Phone +41 616878333
Email global.trial_information@roche.com

Study information

Study designRelative bioavailability study in 14 healthy volunteers
Primary study designInterventional
Secondary study design
Study setting(s)Pharmaceutical testing facility
Study typeOther, Safety
Participant information sheet Not available in web format
Scientific titlePhase I trial: Quotient code QSC301813
Study objectivesThe 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 13/09/2024, London – Brent Research Ethics Committee (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8117; brent.rec@hra.nhs.uk), ref: 24/LO/0348

Health condition(s) or problem(s) studiedThe 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.
InterventionThe 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 typeDrug
Pharmaceutical study type(s)Pharmacokinetic, Relative bioavailability
PhasePhase 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 measureThe 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 measuresThe 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 date15/07/2024
Completion date29/01/2025

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexBoth
Target number of participants14
Key inclusion criteriaHealthy volunteer
Key exclusion criteriaThe 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 enrolment16/09/2024
Date of final enrolment29/01/2025

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Carmot Therapeutics (United States)
Industry

740 Heinz Avenue
Berkeley
CA 94710
United States of America

Phone +1 (888) 402-4674
Email global.trial_information@roche.com
Website https://carmot-therapeutics.us/
ROR logo "ROR" https://ror.org/05ye86j67

Funders

Funder type

Industry

Carmot Therapeutics, Inc.

No information available

Results and Publications

Intention to publish date29/07/2027
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planFull 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 may be posted on or after the date of publication of full trial details.
IPD sharing planThe 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.

Editorial Notes

25/09/2024: Ethics approval details added.
01/08/2024: Study's existence confirmed by the MHRA.