Phase I Study: Quotient Code QSC303166
| ISRCTN | ISRCTN47999700 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47999700 |
| IRAS number | 1012021 |
| Secondary identifying numbers | Quotient code QSC303166 |
- Submission date
- 01/09/2025
- Registration date
- 02/09/2025
- Last edited
- 02/09/2025
- Recruitment status
- Not yet 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. Full details will be added to the study record within 30 months after the trial has ended.
Contact information
Dr Litza McKenzie
Principal Investigator
Principal Investigator
Quotient Sciences Limited, Mere Way, Ruddington Fields, Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0) 330 303 1000 |
|---|---|
| recruitment@weneedyou.co.uk |
Dr . Novartis Study Director
Public, Scientific
Public, Scientific
Lichtstrasse 35
Basel
4056
Switzerland
| Phone | +41 61 324 11 11 |
|---|---|
| novartis.email@novartis.com |
Study information
| Study design | Pharmacokinetic and food effect study in healthy volunteers |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Partially randomised study |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Phase I Study: Quotient Code QSC303166 [the full scientific title will be published within 30 months after the end of the trial] |
| Study acronym | Not applicable |
| 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 01/07/2025, Wales Research Ethics Committee 2 (Health and Care Research Wales, Castlebridge 5, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 2920 230 457; Wales.REC2@wales.nhs.uk), ref: 25/WA/0163 |
| 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. 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. Full details will be added to the study record within 30 months after the trial has ended. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacokinetic |
| 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. 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. 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. Full details will be added to the study record within 30 months after the trial has ended. |
| Overall study start date | 01/07/2025 |
| Completion date | 30/03/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 64 |
| Key inclusion criteria | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. 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. 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 | 30/03/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Quotient Sciences Limited
Mere Way, Ruddington Fields, Ruddington
Nottingham
NG11 6JS
United Kingdom
Nottingham
NG11 6JS
United Kingdom
Sponsor information
Novartis Pharmaceuticals UK Limited
Industry
Industry
2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane
London
W12 7FQ
England
United Kingdom
| Phone | +41 61 324 11 11 |
|---|---|
| novartis.email@novartis.com |
Funders
Funder type
Industry
Novartis Pharmaceuticals UK Limited
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Novartis UK, NOVARTIS UK LIMITED
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2028 |
|---|---|
| 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 of the 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 trial details. |
| IPD sharing plan | Not expected to be made available |
Editorial Notes
01/09/2025: Trial's existence confirmed by MHRA.
