Phase I trial: CA47303
| ISRCTN | ISRCTN23370352 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23370352 |
| IRAS number | 1011728 |
| Secondary identifying numbers | CA47303 |
- Submission date
- 08/04/2025
- Registration date
- 10/04/2025
- Last edited
- 10/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
Plain English Summary
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
Public, Scientific, Principal Investigator
22-24 Lisburn Road
Belfast
BT9 6AD
United Kingdom
 ORCID ID |
0000-0001-7772-7724 |
|---|---|
| Phone | +44 2890 554040 |
| nadine.abdullah@celerion.com |
Study information
| Study design | Relative Bioavailability study in 20 healthy adult female volunteers |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Phase I trial: CA47303 |
| Study hypothesis | 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) |
1. Approved 02/04/2025, East of England - Cambridge East Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, United Kingdom; +44 207 104 8096; cambridgeeast.rec@hra.nhs.uk), ref: IRAS ID 1011728 2. Approved 02/04/2025, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 2030806000; info@mhra.gov.uk), ref: IRAS ID 1011728 |
| Condition | Healthy volunteers |
| 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) | Relative Bioavailability |
| 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 | 04/05/2025 |
| Overall study end date | 14/05/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target number of participants | 20 |
| Participant inclusion criteria | Healthy human volunteer |
| Participant 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. |
| Recruitment start date | 16/04/2025 |
| Recruitment end date | 18/04/2025 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Belfast
BT9 6AD
United Kingdom
Sponsor information
Industry
100 Alhambra Granada Boulevard, Caguas
Puerto Rico
00725
United States of America
| Phone | +1-862-701-5097 |
|---|---|
| herman.ellman@millicentpharma.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 14/11/2027 |
|---|---|
| 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 will 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
10/04/2025: Trial's existence confirmed by MHRA.
