Phase I Trial: Quotient Code QSC302246
| ISRCTN | ISRCTN80239074 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80239074 |
| IRAS number | 1012925 |
| Secondary identifying numbers | Quotient code QSC302246 |
- Submission date
- 05/11/2025
- Registration date
- 05/11/2025
- Last edited
- 07/11/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Deferred
- Condition category
- Not Specified
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 Nand Singh
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 |
Mr David McCoubrey
Public, Scientific
Public, Scientific
Galen Limited, Seagoe Industrial Estate
Craigavon
BT63 5UA
United Kingdom
| Phone | 028 3833 4974 |
|---|---|
| regulatoryaffairs@almacgroup.com |
Study information
| Study design | Bioavailability and pharmacokinetic study in healthy volunteers. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Phase I Study: Quotient Code QSC302246 [the full scientific title will be published within 30 months after the end of the trial] |
| 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 29/09/2025, 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/0653 |
| 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 |
| 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. 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 | 29/09/2025 |
| Completion date | 06/01/2026 |
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. Full details will be added to the study record within 30 months after the trial has ended. |
| Date of first enrolment | 28/11/2025 |
| Date of final enrolment | 20/12/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Quotient Sciences Limited
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
Sponsor information
Galen Limited
Industry
Industry
Seagoe Industrial Estate
Craigavon
BT63 5UA
United Kingdom
| Phone | 028 3833 4974 |
|---|---|
| regulatoryaffairs@almacgroup.com |
Funders
Funder type
Not defined
Galen Limited
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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
05/11/2025: Trial's existence confirmed by MHRA.
