Phase I trial: HMR code: 24-001
| ISRCTN | ISRCTN44913564 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44913564 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1010262 |
| Protocol serial number | IRAS 1010262, HMR Code: 24-001 |
| Sponsor | Nxera Pharma UK Limited |
| Funder | Nxera Pharma UK Limited |
- Submission date
- 17/09/2024
- Registration date
- 01/10/2024
- Last edited
- 05/11/2024
- 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
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
| Primary study design | Interventional |
|---|---|
| Study design | A randomized, placebo-controlled crossover MRI interventional study involving a caffeine challenge |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 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 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 |
| 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 |
| 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(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. |
| Key secondary outcome measure(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. |
| Completion date | 15/11/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 24 |
| Key inclusion criteria | Healthy human volunteers |
| 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 | 21/10/2024 |
| Date of final enrolment | 15/08/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Institute of Psychiatry, Psychology and Neuroscience (IoPPN)
De Crespigny Park
London
SE5 8AF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| 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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/11/2024: A contact was removed.
23/09/2024: Study's existence confirmed by the MHRA.
