Phase I trial, BDD code: BDD21288
| ISRCTN | ISRCTN98634795 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98634795 |
| IRAS number | 1007309 |
| Secondary identifying numbers | IRAS 1007309 |
- Submission date
- 20/12/2023
- Registration date
- 21/12/2023
- Last edited
- 21/12/2023
- 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 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
Dr Lyn Corry
Public, Scientific, Principal Investigator
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 (0)141 552 8791 |
| lyn.corry@bddpharma.com |
Study information
| Study design | Pharmacoscintigraphic open-label crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Other |
| Scientific title | Phase I trial, BDD code: BDD21288 |
| 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 27/09/2023, London - Westminster Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8066; westminster.rec@hra.nhs.uk), ref: 23/LO/0126 |
| 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 | 01/12/2022 |
| Completion date | 07/12/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Male |
| Target number of participants | 12 |
| Total final enrolment | 12 |
| 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 | 30/10/2023 |
| Date of final enrolment | 23/11/2023 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
BDD Pharma Ltd
Glasgow Royal Infirmary
84 Castle Street
Glasgow
G4 0SF
United Kingdom
84 Castle Street
Glasgow
G4 0SF
United Kingdom
Sponsor information
BDD Pharma Ltd
Industry
Industry
Bio-Imaging Centre
Basement Medical Block
Within Glasgow Royal Infirmary
84 Castle Street
Glasgow
G4 0SF
Scotland
United Kingdom
| Phone | +44 (0)1415528791 |
|---|---|
| laura.gow@bddpharma.com |
Funders
Funder type
Hospital/treatment centre
Cincinnati Children's Hospital Medical Center
Government organisation / Other non-profit organizations
Government organisation / Other non-profit organizations
- Alternative name(s)
- Cincinnati Children's, Hospital Pediátrico y Centro Médico de Cincinnati, CCHMC
- Location
- United States of America
Results and Publications
| Intention to publish date | 07/12/2024 |
|---|---|
| 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 | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
21/12/2023: Study's existence confirmed by London - Westminster Research Ethics Committee.
