Phase I trial, HMR code: 22-016
| ISRCTN | ISRCTN17231793 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17231793 |
| IRAS number | 1007377 |
| Secondary identifying numbers | IRAS 1007377, HMR code: 22-016 |
- 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
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 Steve Warrington
Principal Investigator
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 |
Dr Steve Warrington
Scientific
Scientific
HMR, Cumberland Avenue
London
NW10 7EW
United Kingdom
| Phone | +44 (0)20 8961 4130 |
|---|---|
| rec@hmrlondon.com |
Study information
| Study design | First-in-human safety, pharmacokinetics and pharmacodynamics trial in up to 104 heathy volunteers |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomized controlled; parallel; partial crossover; open-label, crossover trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format |
| 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 |
| 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 | 20/02/2023 |
| Completion date | 29/11/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Up to 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
- England
- United Kingdom
Study participating centre
Hammersmith Medicines Research (HMR)
Cumberland Avenue
London
NW10 7EW
United Kingdom
London
NW10 7EW
United Kingdom
Sponsor information
Nxera Pharma UK Ltd
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 Ltd
No information available
Results and Publications
| Intention to publish date | 29/05/2027 |
|---|---|
| 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
18/04/2024: 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.
