Phase 1 trial HMR code: 22-017
| ISRCTN | ISRCTN51803225 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51803225 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1007409 |
| Protocol serial number | IRAS 1007409; HMR code: 22-017 |
| Sponsor | Neurocrine Biosciences (United States) |
| Funder | Neurocrine Biosciences |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Phase I study |
| Secondary study design | Randomised controlled, randomized crossover, randomized parallel |
| Study type | Participant information sheet |
| 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 |
| 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 | 05/12/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- 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
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).
