Phase I Trial, Quotient Code: QSC300320
| ISRCTN | ISRCTN28849775 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28849775 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | 2022‐002756‐39 |
| Integrated Research Application System (IRAS) | 1006328 |
| Protocol serial number | IRAS 1006328, Quotient Code: QSC300320 |
| Sponsor | Norgine (United Kingdom) |
| Funder | Norgine |
- Submission date
- 23/09/2022
- Registration date
- 05/10/2022
- Last edited
- 14/02/2024
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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. The 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
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)330 303 1000 |
|---|---|
| recruitment@weneedyou.co.uk |
Scientific
Norgine House
Widewater Place
Moorhall Road
Uxbridge
UB9 6NS
United Kingdom
| Phone | +44(0)1895453584 |
|---|---|
| rng@norgine.com |
Public
Norgine House
Widewater Place
Moorhall Road
Uxbridge
UB9 6NS
United Kingdom
| Phone | +44(0)1895453736 |
|---|---|
| jpilot@norgine.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Efficacy and safety trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Phase I Trial, Quotient Code: QSC300320 [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) | 1. Approved 25/10/2022, South Central - Oxford A REC (Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 6PN, UK; +44 (0)207 104 8290, (0)207 104 8206, (0)207 104 8061; oxforda.rec@hra.nhs.uk); Ref - 22/SC/0294 2. Approved 25/10/2022, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, UK; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 00322/0315/001-0001 |
| Health condition(s) or problem(s) studied | Healthy volunteers |
| 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 | 10/01/2024 |
| Reason abandoned (if study stopped) | Other reason not related to safety |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 126 |
| Key inclusion criteria | Healthy human volunteer |
| Key exclusion 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. |
| Date of first enrolment | 20/10/2022 |
| Date of final enrolment | 26/05/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Ruddington Fields
Ruddington
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 | The datasets generated 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 nontherapeutic clinical trials. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/02/2024: The following changes have been made:
1. The overall study end date was changed from 26/05/2023 to 10/01/2024.
2. The study was terminated due to another reason not related to safety.
3. A 30-month extension of the deferral from the overall study end date has been granted.
4. The intention to publish date was changed from 26/11/2025 to 10/07/2026.
17/11/2022: Ethics approval added.
16/11/2022: Deferral confirmed by the Health Research Authority.
05/10/2022: Trial's existence confirmed by the Medical & Healthcare products Regulatory Agency (MHRA).
