Phase I trial, HMR code: 22-016
| ISRCTN | ISRCTN17231793 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17231793 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1007377 |
| Protocol serial number | IRAS 1007377, HMR code: 22-016 |
| Sponsor | Nxera Pharma UK Ltd |
| Funder | Nxera Pharma UK Ltd |
- Submission date
- 30/05/2023
- Registration date
- 15/06/2023
- Last edited
- 18/04/2024
- 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
HMR, Cumberland Avenue
London
NW10 7EW
United Kingdom
 ORCID ID |
0000-0003-1602-4536 |
|---|---|
| Phone | +44 (0)20 8961 4130 |
| rec@hmrlondon.com |
Scientific
HMR, Cumberland Avenue
London
NW10 7EW
United Kingdom
| Phone | +44 (0)20 8961 4130 |
|---|---|
| rec@hmrlondon.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | First-in-human safety, pharmacokinetics and pharmacodynamics trial in up to 104 heathy volunteers |
| Secondary study design | Randomized controlled; parallel; partial crossover; open-label, crossover trial |
| Study type | Participant information sheet |
| Scientific title | Phase I trial, HMR code: 22-016 [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 25/05/2023, London – Brent Research Ethics Committee (80 London Road, Skipton House, SE1 6LH, UK; +44 (0)207 104 8137; brent.rec@hra.nhs.uk), ref: 23/LO/0154 2. Approved 15/06/2023, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, UK; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 42719/0014/001-0001 |
| 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 | 29/11/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 104 |
| 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 | 16/06/2023 |
| Date of final enrolment | 15/08/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
London
NW10 7EW
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
18/04/2024: The sponsor and funder name was changed from 'Heptares Therapeutics (United Kingdom)' to 'Nxera Pharma UK Ltd'.
19/07/2023: Ethics approval updated.
01/06/2023: Study's existence confirmed by the HRA.
