Phase I Trial: Quotient Code QSC302246
| ISRCTN | ISRCTN80239074 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80239074 |
| Integrated Research Application System (IRAS) | 1012925 |
| Quotient code | QSC302246 |
| Sponsor | Galen Limited |
| Funder | Galen Limited |
- Submission date
- 05/11/2025
- Registration date
- 05/11/2025
- Last edited
- 05/05/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Not Specified
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
Galen Limited, Seagoe Industrial Estate
Craigavon
BT63 5UA
United Kingdom
| Phone | +44 (0)28 3833 4974 |
|---|---|
| regulatoryaffairs@almacgroup.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Bioavailability and pharmacokinetic study in healthy volunteers. |
| Secondary study design | Randomised controlled trial |
| 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) |
Approved 10/11/2025, 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 |
| 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(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. |
| 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. The full details will be added to the study record within 30 months after the trial has ended. |
| Completion date | 07/01/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 8 |
| Total final enrolment | 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 | 01/12/2025 |
| Date of final enrolment | 07/01/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
05/05/2026: The following changes were made to the study record:
1. The date of first enrolment was changed from 28/11/2025 to 01/12/2025.
2. The date of final enrolment was changed from 20/12/2025 to 07/01/2026.
3. The completion date was changed from 06/01/2026 to 07/01/2026.
4. Final enrolment number added.
15/12/2025: Ethics approval details added.
05/11/2025: Trial's existence confirmed by MHRA.
