Phase I trial: Quotient Code QSC207871
| ISRCTN | ISRCTN12178605 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12178605 |
| IRAS number | 1009805 |
| Secondary identifying numbers | IRAS ID 1009805, QSC207871 |
- Submission date
- 09/08/2024
- Registration date
- 12/08/2024
- Last edited
- 12/08/2024
- 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 Stuart Mair
Principal Investigator
Principal Investigator
Quotient Sciences Ltd
Mere Way, Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0) 3303031000 |
|---|---|
| recruitment@weneedyou.co.uk |
Mr Sachin Desai
Public, Scientific
Public, Scientific
Novartis Pharma AG
Lichtstrasse 35
Basel
4056
Switzerland
| Phone | +1 617 852 3616 |
|---|---|
| sachin.desai@novartis.com |
Study information
| Study design | First-in-man safety tolerability and pharmacokinetic study in approximately 43 healthy participants |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Safety |
| Participant information sheet | Not available in web format |
| Scientific title | Phase I trial: Quotient code QSC207871 [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 26/07/2024, Wales Research Ethics Committee 2 (Health and Care Research Wales, Castlebridge 5, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 02922941119; Wales.REC2@wales.nhs.uk), ref: 24/WA/0158 |
| 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 |
| Pharmaceutical study type(s) | Pharmacokinetic, Pharmacogenetic |
| 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 | 05/06/2024 |
| Completion date | 03/02/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 43 |
| 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. The full details will be added to the study record within 30 months after the trial has ended. |
| Date of first enrolment | 13/08/2024 |
| Date of final enrolment | 03/02/2025 |
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
Novartis Pharma AG
Industry
Industry
Lichtstrasse 35
Basel
4056
Switzerland
| Phone | +1 617 852 3616 |
|---|---|
| sachin.desai@novartis.com |
Funders
Funder type
Industry
Novartis Pharma AG
No information available
Results and Publications
| Intention to publish date | 02/08/2027 |
|---|---|
| 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 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 or non-therapeutical clinical trials. |
Editorial Notes
09/08/2024: Study's existence confirmed by the MHRA.
