Phase I trial: Fortrea Phase I unit Leeds
| ISRCTN | ISRCTN22812347 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22812347 |
| EudraCT/CTIS number | 2024-000381-25 |
| IRAS number | 1009954 |
| Secondary identifying numbers | IRAS 1009954 Fortrea Phase I unit Leeds |
- Submission date
- 09/01/2025
- Registration date
- 10/01/2025
- Last edited
- 10/01/2025
- Recruitment status
- No longer 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 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
Dr Jim Bush
Principal Investigator
Principal Investigator
Fortrea Clinical Research Unit Ltd
Drapers Yard
Marshall St
Holbeck
Leeds
LS11 9EH
United Kingdom
| Phone | +44 (0)1133013590 |
|---|---|
| ukirelandregethics@fortrea.com |
Mr Clinical Scientist
Scientific
Scientific
Roervangsvej, 30
Holbaek
4300
Denmark
| Phone | +45 (0)59 48 59 59 |
|---|---|
| info@pharmacosmos.com |
Mr Head Of Clinical Development
Public
Public
Roervangsvej 30
Holbaek
4300
Denmark
| Phone | +45 (0)59 48 59 59 |
|---|---|
| info@pharmacosmos.com |
Study information
| Study design | Human AME trial in 6 healthy volunteers and 6 iron-overloaded patients |
|---|---|
| Primary study design | Interventional |
| Secondary study design | |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Treatment |
| Participant information sheet | Not available in web format |
| Scientific title | Phase I trial: Fortrea Phase I unit Leeds [The full scientific title will be published within 30 months after the end of the trial] |
| Study objectives | 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. |
| Ethics approval(s) |
Approved 12/11/2024, North East-York (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8079; york.rec@hra.nhs.uk), ref: 24/NE/0138 |
| Health condition(s) or problem(s) studied | 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 | 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 |
| Pharmaceutical study type(s) | Pharmacokinetic, Pharmacodynamic |
| 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 | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 29/09/2024 |
| Completion date | 27/02/2025 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 12 |
| 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 | 28/11/2024 |
| Date of final enrolment | 12/02/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Fortrea Phase I unit
Drapers Yard
Marshall Street
Leeds
LS 11 9EH
United Kingdom
Marshall Street
Leeds
LS 11 9EH
United Kingdom
Sponsor information
Pharmacosmos (Denmark)
Industry
Industry
Roervangsvej 30
Holbaek
4300
Denmark
| Phone | +45 (0)59 48 59 59 |
|---|---|
| info@pharmacosmos.com | |
| Website | https://www.pharmacosmos.com/ |
"ROR" |
https://ror.org/04g1gk322 |
Funders
Funder type
Industry
Pharmacosmos
No information available
Results and Publications
| Intention to publish date | 01/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Full trial details will be published up to 30 months after the end of the trial. Publication of some trial details is deferred because of the high commercial sensitivity of this Phase I study and the negligible benefit to the public of Phase I information. Results may be posted on or after the date of publication of full trial details. |
| 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. |
Editorial Notes
09/01/2025: Study's existence confirmed by the HRA.
