Evaluation of NBI-1117570 in adults with stable schizophrenia
| ISRCTN | ISRCTN18014168 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18014168 |
| Integrated Research Application System (IRAS) | 1013028 |
| Sponsor | Neurocrine Biosciences (United States) |
| Funder | Neurocrine Biosciences |
- Submission date
- 09/04/2026
- Registration date
- 10/04/2026
- Last edited
- 10/04/2026
- Recruitment status
- Recruiting
- Overall study status
- Deferred
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
The Health Research Authority (HRA) has approved 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
1A Newcomen Street, London Bridge
London
SE1 1YR
United Kingdom
 ORCID ID |
0000-0002-0010-207X |
|---|---|
| Phone | +44 20 7042 5800 |
| j.taubel@richmondpharmacology.com |
Scientific, Public
Neurocrine Biosciences, Inc.
6027 Edgewood Bend Court
San Diego
CA 92130
United States of America
| Phone | +1-877-641-3461 |
|---|---|
| medinfo@neurocrine.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | N/A: single arm study |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Sequential |
| Purpose | Treatment |
| Scientific title | A phase 1b, single-center, open-label, intra-participant rising dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of NBI-1117570 monotherapy in adults with stable schizophrenia |
| Study objectives | |
| Ethics approval(s) |
Approved 17/03/2026, London – London Bridge (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8229; londonbridge.rec@hra.nhs.uk), ref: 26/LO/0002 |
| Health condition(s) or problem(s) studied | Schizophrenia |
| Intervention | The Health Research Authority (HRA) has approved 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 Health Research Authority (HRA) has approved 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 Health Research Authority (HRA) has approved 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) | |
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | All |
| Target sample size at registration | 24 |
| Key inclusion criteria | The Health Research Authority (HRA) has approved 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 exclusion criteria | The Health Research Authority (HRA) has approved 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 | 13/04/2026 |
| Date of final enrolment | 30/09/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
London
SE1 1YR
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
09/04/2026: Trial's existence confirmed by London – London Bridge REC.
