Phase I Study: Quotient Code QSC303166
| ISRCTN | ISRCTN47999700 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47999700 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1012021 |
| Protocol serial number | Quotient code QSC303166 |
| Sponsor | Novartis Pharmaceuticals UK Limited |
| Funder | Novartis Pharmaceuticals UK Limited |
- Submission date
- 01/09/2025
- Registration date
- 02/09/2025
- Last edited
- 02/09/2025
- Recruitment status
- Recruiting
- Overall study status
- Deferred
- Condition category
- Other
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
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 |
Public, Scientific
Lichtstrasse 35
Basel
4056
Switzerland
| Phone | +41 61 324 11 11 |
|---|---|
| novartis.email@novartis.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pharmacokinetic and food effect study in healthy volunteers |
| Secondary study design | Partially randomised study |
| Study type | 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 |
| 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(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. |
| 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. Full details will be added to the study record within 30 months after the trial has ended. |
| Completion date | 30/03/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
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 | Not expected to be made available |
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
01/09/2025: Trial's existence confirmed by MHRA.
