Phase I Trial, Quotient Code: QSC207970
| ISRCTN | ISRCTN12615820 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12615820 |
| EudraCT/CTIS number | 2022-002263-30 |
| IRAS number | 1007036 |
| Secondary identifying numbers | IRAS 1007036, Quotient Code: QSC207970 |
- Submission date
- 13/02/2023
- Registration date
- 16/02/2023
- Last edited
- 20/09/2023
- Recruitment status
- No longer 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 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
Dr Nand Singh
Principal Investigator
Principal Investigator
Quotient Sciences Limited
Mere Way
Ruddington Fields
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)330 303 1000 |
|---|---|
| recruitment@weneedyou.co.uk |
Mr Regulatory Affairs
Scientific
Scientific
33 Kingsway
London
WC2B 6UF
United Kingdom
| Phone | +44 2030534200 |
|---|---|
| shionogiclintrials-admin@shionogi.co.jp |
Mr Regulatory Affairs
Public
Public
33 Kingsway
London
WC2B 6UF
United Kingdom
| Phone | +44 2030534200 |
|---|---|
| shionogiclintrials-admin@shionogi.co.jp |
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 | No participant information sheet available |
| Scientific title | Phase I Trial, Quotient Code: QSC207970 [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 22/03/2023, London - Surrey Borders (London HRA Centre, 2nd Floor, 2 Redman Place, Stratford, London, E20 1JQ; surreyborders.rec@hra.nhs.uk), ref: 23/LO/0015 2. Approved 22/03/2023, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, UK; +44 (0)20 3080 6000; info@mhra.gov.uk) ref: CTA 50999/0014/001-0001 |
| 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 |
| Pharmaceutical study type(s) | |
| 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 | 31/01/2023 |
| Completion date | 08/05/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 6 |
| 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 | 03/04/2023 |
| Date of final enrolment | 23/04/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Quotient Sciences Limited
Mere Way
Ruddington Fields
Nottingham
NG11 6JS
United Kingdom
Ruddington Fields
Nottingham
NG11 6JS
United Kingdom
Sponsor information
Shionogi B.V.
Industry
Industry
33 Kingsway
London
WC2B 6UF
England
United Kingdom
| Phone | +44 2030534200 |
|---|---|
| shionogiclintrials-admin@shionogi.co.jp | |
| Website | https://www.shionogi.com |
Funders
Funder type
Industry
Shionogi B.V.
No information available
Results and Publications
| Intention to publish date | 08/11/2025 |
|---|---|
| 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 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. |
| 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 | 20/09/2023 | No | No |
Editorial Notes
20/09/2023: A link to the HRA research summary was added.
23/03/2023: The ethics approval was added.
16/02/2023: Trial's existence confirmed by MHRA.
