Phase 1 trial HMR code: 22-017
| ISRCTN | ISRCTN51803225 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51803225 |
| IRAS number | 1007409 |
| Secondary identifying numbers | IRAS 1007409; HMR code: 22-017 |
- Submission date
- 26/05/2023
- Registration date
- 03/08/2023
- Last edited
- 15/05/2025
- 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)208 961 4130 |
| rec@hmrlondon.com |
Scientific
Neurocrine Biosciences, Inc.
12780 El Camino Real
San Diego
CA 92130
United States of America
| Phone | +1-877-641-3461 |
|---|---|
| medinfo@neurocrine.com |
Study information
| Study design | Phase I study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled, randomized crossover, randomized parallel |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format. |
| Scientific title | Phase 1 trial HMR code: 22-017 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 12/06/2023, London – Brent Research Ethics Committee (80 London Road, Skipton House, London, SE1 6LH, United Kingdom; +44 (0)207 104 8128; brent.rec@hra.nhs.uk), ref: 23/LO/0178 2 2. Approved 27/07/2023, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 17346/0212/001-0001 |
| 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 | 10/03/2023 |
| Completion date | 05/12/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target number of participants | Up to 134 |
| 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 | 08/08/2023 |
| Date of final enrolment | 17/01/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
NW10 7EW
United Kingdom
Sponsor information
Industry
12780 El Camino Real
San Diego
CA 92130
United States of America
| Phone | +1-877-641-3461 |
|---|---|
| medinfo@neurocrine.com | |
"ROR" |
https://ror.org/05d84mm26 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Neurocrine Biosciences, Inc.
- Location
- United States of America
Results and Publications
| Intention to publish date | 05/06/2027 |
|---|---|
| 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 1 study and the negligible benefit to the public of phase 1 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
15/05/2025: The following changes were made:
1. The recruitment end date was changed from 15/11/2024 to 17/01/2024.
2. The overall study end date was changed from 15/02/2025 to 05/12/2024.
3. The intention to publish date was changed from 15/08/2027 to 05/06/2027.
07/08/2023: Internal review.
21/06/2023: Trial's existence confirmed by the Medicines & Healthcare products Regulatory Agency (MHRA) (UK).
