Phase I Trial: Quotient Code QSC301642
| ISRCTN | ISRCTN73208723 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73208723 |
| IRAS number | 1011435 |
| Secondary identifying numbers | Quotient Code: QSC301642 |
- Submission date
- 03/04/2025
- Registration date
- 07/04/2025
- Last edited
- 07/04/2025
- 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
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 Regulatory Affairs Department
Public, Scientific
Public, Scientific
Shionogi B.V., Herengracht 464
Amsterdam
1017 CA
Netherlands
| Phone | +44 (0)20 3053 4200 |
|---|---|
| regulatory.affairs@shionogi.eu |
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 |
Study information
| Study design | Absorption metabolism distribution and elimination (ADME) study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Other |
| Participant information sheet | Not available in web format |
| Scientific title | Phase I Trial: Quotient Code QSC301642 |
| Study hypothesis | 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 03/03/2025, London - Surrey Borders Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, United Kingdom; +44 (0)20 7104 8057; surreyborders.rec@hra.nhs.uk), ref: 25/LO/0104 |
| Condition | 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 | 03/03/2025 |
| Overall study end date | 08/06/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 30 Years |
| Upper age limit | 65 Years |
| Sex | Male |
| Target number of participants | 7 |
| Participant 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. |
| Participant 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. |
| Recruitment start date | 05/05/2025 |
| Recruitment end date | 08/06/2025 |
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
Shionogi B.V.
Industry
Industry
Herengracht 464
Amsterdam
1017 CA
Netherlands
| Phone | +44 (0)20 3053 4200 |
|---|---|
| regulatory.affairs@shionogi.eu | |
| Website | https://www.shionogi.com/eu/en/ |
Funders
Funder type
Not defined
Shionogi B.V.
No information available
Results and Publications
| Intention to publish date | 08/12/2027 |
|---|---|
| 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 | 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 non-therapeutic clinical trials. |
Editorial Notes
07/04/2025: Study's existence confirmed by Medicines and Healthcare products Regulatory Agency (MHRA) (UK)
