Deferred registration: Phase I Trial: MAC code 'MAC215'
| ISRCTN | ISRCTN10994097 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10994097 |
| Integrated Research Application System (IRAS) | 1013343 |
| Sponsor | Neurocrine Biosciences (United States) |
| Funder | Neurocrine Biosciences |
- Submission date
- 17/06/2026
- Registration date
- 17/06/2026
- Last edited
- 17/06/2026
- Recruitment status
- Recruiting
- Overall study status
- Deferred
- Condition category
- Other
Plain English summary of protocol
The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date.
Contact information
Public
6027 Edgewood Bend Court
San Diego
92130
United States of America
| auchimoto@neurocrine.com |
Scientific
6027 Edgewood Bend Court
San Diego
92130
United States of America
| pdalen@neurocrine.com |
Principal investigator
Neuroscience Centre of Excellence, Citylabs, Nelson Street
Manchester
M13 9NQ
United Kingdom
| Phone | +44 161 275 9966 |
|---|---|
| giuseppefiore@macplc.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Placebo |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Deferred registration: Phase I Trial: MAC code 'MAC215' [Full scientific title to be added on or before the deferral expiry date] |
| Study objectives | The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date. |
| Ethics approval(s) |
Approved 10/04/2026, Wales REC 1 (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; -; Wales.REC1@wales.nhs.uk), ref: 26/WA/0028 |
| Health condition(s) or problem(s) studied | The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date. |
| Intervention | The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date. |
| 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) |
|
| Key secondary outcome measure(s) | |
| Completion date | 11/03/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 50 Years |
| Upper age limit | 85 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date. |
| Key exclusion criteria | The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date. |
| Date of first enrolment | 22/05/2026 |
| Date of final enrolment | 15/02/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
Study participating centres
Nelson St
Manchester
M13 9NQ
England
Sabatier Close
Stockton-on-Tees
TS17 6EW
England
Exchange House
Watling Street
Cannock
South Staffordshire
WS11 0BN
England
Kaman Court
1 Faraday Way
Blackpool
FY2 0JH
England
Maple Road
Barnsley
S75 3DL
England
Wakefield Rd
Leeds
LS10 1DU
England
King's Business Park
Liverpool
L34 1BH
England
Glasgow
G20 0XA
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
17/06/2026: Trial's existence confirmed by NHS HRA.
