Phase I trial: HMR code: 24-001
| ISRCTN | ISRCTN44913564 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44913564 |
| IRAS number | 1010262 |
| Secondary identifying numbers | IRAS 1010262, HMR Code: 24-001 |
- Submission date
- 17/09/2024
- Registration date
- 01/10/2024
- Last edited
- 05/11/2024
- Recruitment status
- 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. The full details will be added to the study record within 30 months after the trial has ended.
Contact information
Dr Ndabezinhle Mazibuko
Principal Investigator
Principal Investigator
Centre for Neuroimaging Sciences PO89
Institute of Psychiatry, Psychology and Neuroscience (IoPPN)
De Crespigny Park
London
SE5 8AF
United Kingdom
| Phone | +44 (0)20 3228 3047 |
|---|---|
| peter.hawkins@kcl.ac.uk |
Study information
| Study design | A randomized, placebo-controlled crossover MRI interventional study involving a caffeine challenge |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format |
| Scientific title | Phase I trial: HMR code: 24-001 [The full scientific title will be published within 30 months after the end of the trial] |
| 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) |
Approved 16/07/2024, London - Brent Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 107 8117; brent.rec@hra.nhs.uk), ref: 24/LO/0430 |
| Condition | 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) | 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. |
| 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 | 07/06/2024 |
| Overall study end date | 15/11/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 24 |
| Participant inclusion criteria | Healthy human volunteers |
| 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 | 21/10/2024 |
| Recruitment end date | 15/08/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
King's College London
Centre for Neuroimaging Sciences PO89
Institute of Psychiatry, Psychology and Neuroscience (IoPPN)
De Crespigny Park
London
SE5 8AF
United Kingdom
Institute of Psychiatry, Psychology and Neuroscience (IoPPN)
De Crespigny Park
London
SE5 8AF
United Kingdom
Sponsor information
Nxera Pharma UK Limited
Industry
Industry
Steinmetz Building
Granta Park
Cambridge
CB21 6DG
England
United Kingdom
| Phone | +44 (0)1223 949 100 |
|---|---|
| reception@nxera.life |
Funders
Funder type
Industry
Nxera Pharma UK Limited
No information available
Results and Publications
| Intention to publish date | 15/05/2028 |
|---|---|
| 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 may 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
05/11/2024: A contact was removed.
23/09/2024: Study's existence confirmed by the MHRA.
