Deferred registration: Fortrea code: 783991
| ISRCTN | ISRCTN14255848 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14255848 |
| Integrated Research Application System (IRAS) | 1014630 |
| Sponsor | Lundbeck (Denmark) |
| Funder | H. Lundbeck A/S |
- Submission date
- 03/11/2026
- Registration date
- 03/11/2026
- Last edited
- 03/11/2026
- 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
This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date
Contact information
Dr Jim Bush
Principal investigator, Public, Scientific
Principal investigator, Public, Scientific
Drapers Yard, Marshall St, Holbeck
Leeds
LS11 9EH
United Kingdom
| Phone | +44 (0)1133013644 |
|---|---|
| jim.bush@fortrea.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Non-randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Single |
| Purpose | Absorption, metabolism and excretion (AME) |
| Scientific title | Deferred registration: Fortrea code: 783991 [Full scientific title to be added on or before the deferral expiry date] |
| Study objectives | This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date |
| Ethics approval(s) |
Approved 18/09/2026, East of England - Cambridge Central Research Ethics Committee (2 Redman Place, London, E20 1JQ, United Kingdom; +44 (0)2071048285; cambridgecentral.rec@hra.nhs.uk), ref: 26/EE/0183 |
| Health condition(s) or problem(s) studied | This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date |
| Intervention | This is a phase I trial in healthy volunteers only and qualifies for an automatic 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) | This is a phase I trial in healthy volunteers only and qualifies for an automatic 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 | 27/07/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 16 |
| Key inclusion criteria | This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date |
| Key exclusion criteria | This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date |
| Date of first enrolment | 02/11/2026 |
| Date of final enrolment | 27/07/2027 |
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
03/11/2026: Study's existence confirmed by the East of England - Cambridge Central Research Ethics Committee.
