Phase I trial, Quotient Sciences code: QSC206403
| ISRCTN | ISRCTN45504491 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45504491 |
| EudraCT/CTIS number | 2022-003288-10 |
| IRAS number | 1006587 |
| Secondary identifying numbers | IRAS 1006587, QSC206403 |
- Submission date
- 12/01/2023
- Registration date
- 18/01/2023
- Last edited
- 04/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- 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
Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)330 3031000 |
|---|---|
| recruitment@weneedyou.co.uk |
Public
Am Klopferspitz 19a
Planegg
82152
Germany
| Phone | +1 (0)401 489 1861 |
|---|---|
| jtran@anavexcorp.com |
Scientific
Am Klopferspitz 19a
Planegg
82152
Germany
| Phone | +1 (0)401 489 1861 |
|---|---|
| jtran@anavexcorp.com |
Study information
| Study design | Pharmacokinetics trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Pharmacokinetics trial |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Other |
| Participant information sheet | Not available in web format. |
| Scientific title | Phase I trial, Quotient Sciences code: QSC206403 [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 13/03/2023, London Surrey Borders REC (London HRA Centre, 2nd Floor, 2 Redman Place, Stratford, London, E20 1JQ, UK; surreyborders.rec@hra.nhs.uk), ref: 23/LO/0006 2. Approved 13/03/2023, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, UK; +44 (0) 20 3080 6000; info@mhra.gov.uk), ref: CTA 52215/0005/001-0001 The HRA has approved deferral of publication of trial details. |
| 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 | 22/12/2022 |
| Completion date | 27/07/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 12 |
| Key inclusion criteria | Healthy 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 | 24/04/2023 |
| Date of final enrolment | 27/07/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
Sponsor information
Industry
Am Klopferspitz 19a
Planegg
82152
Germany
| Phone | +1 (212) 332 4449 |
|---|---|
| cmissling@anavexcorp.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 27/01/2026 |
|---|---|
| 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. Results will be posted on or after the date of publication of full 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
04/04/2023: Ethics approval details added. The recruitment start date was changed from 07/03/2023 to 24/04/2023.
17/03/2023: The HRA has confirmed that it has approved deferral.
08/02/2023: The study setting has been changed from ‘Other’.
18/01/2023: Trial's existence confirmed by the MHRA.
