Phase I trial: CA47303
| ISRCTN | ISRCTN23370352 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23370352 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1011728 |
| Protocol serial number | CA47303 |
| Sponsor | Millicent Puerto Rico LLC |
| Funder | Millicent Puerto Rico LLC |
- 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
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 Nadine Abdullah
Public, Scientific, Principal investigator
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
| Primary study design | Interventional |
|---|---|
| Study design | Relative Bioavailability study in 20 healthy adult female volunteers |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | Phase I trial: CA47303 |
| 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) |
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 |
| Health condition(s) or problem(s) studied | 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 |
| 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) | 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 secondary outcome measure(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. |
| Completion 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 sample size at registration | 20 |
| Key inclusion criteria | Healthy human volunteer |
| 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 | 16/04/2025 |
| Date of final enrolment | 18/04/2025 |
Locations
Countries of recruitment
- United Kingdom
- Northern Ireland
Study participating centre
Celerion GB Ltd
22-24 Lisburn Road
Belfast
BT9 6AD
United Kingdom
Belfast
BT9 6AD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/04/2025: Trial's existence confirmed by MHRA.
