Phase 1 trial: CA38951
| ISRCTN | ISRCTN46343886 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46343886 |
| IRAS number | 1006327 |
| Secondary identifying numbers | IRAS 1006327, CA38951 |
- Submission date
- 09/02/2024
- Registration date
- 14/02/2024
- Last edited
- 14/02/2024
- 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 | Phase 1 bioavailability study in 36 healthy 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 1 trial: CA38951 |
| 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 10/11/2022, London - West London & GTAC Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, United Kingdom; +44 207 1048 007; westlondon.rec@hra.nhs.uk), ref: 22/LO/0682 2. Approved 10/11/2022, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 20 3080 6000;; info@mhra.gov.uk), ref: CTA 55384/0004/001-0001 |
| 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 | Other |
| 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 | 08/09/2022 |
| Overall study end date | 10/03/2023 |
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 | 36 |
| Participant 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. |
| 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 | 21/11/2022 |
| Recruitment end date | 11/12/2022 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Belfast
BT9 6AD
United Kingdom
Sponsor information
Industry
Block 4, Floor 2
Quayside Business Park, Mill Street
Dundalk
A91 KA9R
Ireland
| Phone | +1 862 701-5097 |
|---|---|
| herman.ellman@millicentpharma.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 10/09/2025 |
|---|---|
| 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 may 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
14/02/2024: Trial's existence confirmed by London - West London & GTAC Research Ethics Committee
