Phase 1b trial, BDD code: BDD22306b
| ISRCTN | ISRCTN14216648 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14216648 |
| IRAS number | 1010244 |
| Secondary identifying numbers | BDD22306b |
- Submission date
- 23/10/2024
- Registration date
- 23/10/2024
- Last edited
- 24/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
Plain English summary of protocol
The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 12 months after the trial has ended.
Contact information
Public, Scientific, Principal Investigator
BDD Pharma Ltd
Within Glasgow Royal Infirmary
84 Castle Street
Glasgow
G4 0SF
United Kingdom
 ORCID ID |
0009-0008-4224-4667 |
|---|---|
| Phone | +44 141 552 8791 |
| lyn.corry@bddpharma.com |
Study information
| Study design | Pharmacoscintigraphic open-label crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Other |
| Scientific title | Phase 1b trial, BDD code: BDD22306b |
| Study objectives | The Sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 12 months after the trial has ended. |
| Ethics approval(s) |
Approved 22/08/2024, London - Surrey Borders Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, United Kingdom; +44 2071048057; surreyborders.rec@hra.nhs.uk), ref: 24/LO/0438 |
| Health condition(s) or problem(s) studied | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 12 months after the trial has ended. |
| Intervention | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 12 months after the trial has ended. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacokinetic, Scintigraphy |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 12 months after the trial has ended. |
| Primary outcome measure | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 12 months after the trial has ended. |
| Secondary outcome measures | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 12 months after the trial has ended. |
| Overall study start date | 10/05/2024 |
| Completion date | 14/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 15 |
| Key inclusion criteria | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 12 months after the trial has ended. |
| Key exclusion criteria | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 12 months after the trial has ended. |
| Date of first enrolment | 23/10/2024 |
| Date of final enrolment | 10/06/2025 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
84 Castle Street
Glasgow
G4 0SF
United Kingdom
Sponsor information
Industry
Venlighedsvej 4
2970 Horsholm
Horsholm
2970
Denmark
| Phone | +45 31537180 |
|---|---|
| ab@conterapharma.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 28/02/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Full trial details will be published up to 12 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 | Not provided at time of registration |
Editorial Notes
24/07/2025: The following changes were made to the trial record:
1. The completion date was changed from 28/02/2025 to 14/07/2025.
2. The date of first enrolment was changed from 16/10/2024 to 23/10/2024.
3. The date of final enrolment was changed from 31/01/2025 to 10/06/2025.
23/10/2024: Trial's existence confirmed by London - Surrey Borders Research Ethics Committee.
