Phase I trial: Quotient code QSC301152
| ISRCTN | ISRCTN65070683 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65070683 |
| IRAS number | 1008350 |
| Secondary identifying numbers | IRAS 1008350, QSC301152 |
- Submission date
- 14/12/2023
- Registration date
- 18/12/2023
- Last edited
- 18/12/2023
- 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 Stuart Mair
Principal Investigator
Principal Investigator
Mere Way, Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 3303031000 |
|---|---|
| recruitment@weneedyou.co.uk |
Mr Sachin Desai
Public, Scientific
Public, Scientific
Lichtstrasse 35
Basel
4056
Switzerland
| Phone | +1 617 852 3616 |
|---|---|
| sachin.desai@novartis.com |
Study information
| Study design | First-in-man safety pharmacokinetics and pharmacodynamics trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Safety |
| Participant information sheet | No participant information sheet available |
| Scientific title | Phase I trial: Quotient code QSC301152 [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 06/12/2023, London Chelsea REC (2 Redman Place Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8150; chelsea.rec@hra.nhs.uk), ref: 23/LO/0799 |
| 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) | Pharmacokinetic, Pharmacodynamic |
| 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 | 28/09/2023 |
| Completion date | 07/04/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 88 |
| 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 | 18/12/2023 |
| Date of final enrolment | 07/04/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Quotient Sciences Limited
Mere Way, Ruddington
Nottingham
NG11 6JS
United Kingdom
Nottingham
NG11 6JS
United Kingdom
Sponsor information
Novartis (Switzerland)
Industry
Industry
Lichtstrasse 35
Basel
4056
Switzerland
| Phone | +1 617 852 3616 |
|---|---|
| sachin.desai@novartis.com | |
| Website | https://www.novartis.com/ |
"ROR" |
https://ror.org/02f9zrr09 |
Funders
Funder type
Industry
Novartis Pharma
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Novartis Deutschland GmbH, Novartis Pharma GmbH, Novartis Deutschland
- Location
- Germany
Results and Publications
| Intention to publish date | 07/10/2027 |
|---|---|
| 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 of non-therapeutic clinical trials. |
Editorial Notes
18/12/2023: Study's existence confirmed by the MHRA.
