Deferred registration: Fortrea code: 782153
| ISRCTN | ISRCTN36988003 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36988003 |
| Integrated Research Application System (IRAS) | 1013670 |
| Sponsor | Roche (Switzerland) |
| Funder | F. Hoffmann-La Roche |
- Submission date
- 20/07/2026
- Registration date
- 21/07/2026
- Last edited
- 21/07/2026
- Recruitment status
- 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 requested a deferral. The full details will be added to the trial record on or before the deferral expiry date
Contact information
Dr Somasekhara Menakuru
Public, Scientific, Principal investigator
Public, Scientific, Principal investigator
Drapers Yard, Marshall St, Holbeck
Leeds
LS11 9EH
United Kingdom
| Phone | +44 113 394 5200 |
|---|---|
| som.menakuru@fortrea.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | N/A: single arm study |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Pharmacokinetics |
| Scientific title | Deferred registration: Fortrea code: 782153 Full scientific title to be added on or before the deferral expiry date |
| Study objectives | |
| Ethics approval(s) |
Approved 02/07/2026, London - Brent Research Ethics Committee (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; no telephone number provided; brent.rec@hra.nhs.uk), ref: 26/LO/0132 |
| Health condition(s) or problem(s) studied | The sponsor has requested a deferral. The full details will be added to the trial record on or before the deferral expiry date |
| Intervention | The sponsor has requested a deferral. The 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 sponsor has requested a deferral. The full details will be added to the trial record on or before the deferral expiry date |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 20/04/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 0 Years |
| Upper age limit | 1 Year |
| Sex | All |
| Target sample size at registration | 120 |
| Key inclusion criteria | The sponsor has requested a deferral. The full details will be added to the trial record on or before the deferral expiry date |
| Key exclusion criteria | The sponsor has requested a deferral. The full details will be added to the trial record on or before the deferral expiry date |
| Date of first enrolment | 20/07/2026 |
| Date of final enrolment | 20/04/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Fortrea Clinical Research Unit
Drapers Yard, Marshall St, Holbeck
Leeds
LS11 9EH
England
Leeds
LS11 9EH
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
20/07/2026: Trial's existence confirmed by London - Brent Research Ethics Committee.
