Phase I trial, BDD code: BDD22306
| ISRCTN | ISRCTN79577836 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79577836 |
| Integrated Research Application System (IRAS) | 1007120 |
| Sponsor | Contera Pharma |
| Funder | Contera Pharma |
- Submission date
- 10/10/2023
- Registration date
- 10/10/2023
- Last edited
- 15/05/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Not Specified
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
| Primary study design | Interventional |
|---|---|
| Study design | Two-part exploratory single-centre crossover study in healthy volunteers |
| Secondary study design | Non randomised study |
| Scientific title | Phase I trial, BDD code: BDD22306 |
| 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 22/08/2023, London Bridge Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 2071048387; londonbridge.rec@hra.nhs.uk), ref: 23/LO/0037 |
| 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 | 31/08/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 15 |
| Total final enrolment | 43 |
| 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 | 07/09/2023 |
| Date of final enrolment | 21/05/2026 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
84 Castle Street
Glasgow
G4 0SF
Scotland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
15/05/2026: The date of final enrolment was changed from 08/05/2026 to 21/05/2026.
15/04/2026: The following changes were made to the study record:
1. The study design was changed from 'Pharmacoscintigraphic open-label crossover study' to 'Two-part exploratory single-centre crossover study in healthy volunteers'.
2. The date of final enrolment was changed from 25/09/2023 to 08/05/2026.
3. The completion date was changed from 22/12/2023 to 31/08/2026.
4. Sex was changed from Male Only to All.
5. The target sample size was changed from 15 to 43.
10/10/2023: Trial's existence confirmed by London Bridge Research Ethics Committee.
