Phase I trial, BDD code: BDD21288
| ISRCTN | ISRCTN98634795 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98634795 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1007309 |
| Protocol serial number | IRAS 1007309 |
| Sponsor | BDD Pharma Ltd |
| Funder | Cincinnati Children's Hospital Medical Center |
- 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
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 (0)141 552 8791 |
| lyn.corry@bddpharma.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pharmacoscintigraphic open-label crossover study |
| Secondary study design | Non randomised study |
| 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 |
| 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(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. |
| Key secondary outcome measure(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. |
| 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 sample size at registration | 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
- United Kingdom
- Scotland
Study participating centre
84 Castle Street
Glasgow
G4 0SF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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.
