Phase I trial: Labcorp Drug Development Study: 8479217
| ISRCTN | ISRCTN14340698 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14340698 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | 2021‐005631‐24 |
| Integrated Research Application System (IRAS) | 1004924 |
| Protocol serial number | IRAS 1004924, Labcorp Drug Development Study 8479217 |
| Sponsor | Bergenbio ASA |
| Funder | Bergenbio ASA |
- Submission date
- 28/09/2022
- Registration date
- 14/10/2022
- Last edited
- 14/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
Plain English summary of protocol
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
Principal investigator
Labcorp Clinical Research Unit
Springfield House, Hyde Street
Leeds
LS2 9LH
United Kingdom
| Phone | +44 (0)113 301 3521 |
|---|---|
| ashley.brooks@labcorp.com |
Scientific
Labcorp Clinical Research Unit
Springfield House, Hyde Street
Leeds
LS2 9LH
United Kingdom
| Phone | +44 (0) 113 301 3521 |
|---|---|
| ashley.brooks@labcorp.com |
Public
Labcorp Clinical Research Unit
Springfield House, Hyde Street
Leeds
LS2 9LH
United Kingdom
| Phone | +44 (0) 113 301 3521 |
|---|---|
| ashley.brooks@labcorp.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A mass balance study and metabolic profile investigation |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Phase I trial: Labcorp Drug Development Study: 8479217 [The full scientific title will be published within 30 months after the end of the trial] |
| Study objectives | 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) | Approved 06/07/2022, MHRA and HRA Fast track REC (10 South Colonnade, Canary Wharf, London, E14 4PU, UK; +44 (0)207 104 8012; fasttrack.rec@hra.nhs.uk), ref: CTA 42371/0009/001-0001, REC ref: 22/FT/0036 The HRA has approved deferral of publication of trial details. |
| Health condition(s) or problem(s) studied | 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 | 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 | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | 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. |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 16/09/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 6 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 02/08/2022 |
| Date of final enrolment | 16/09/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Hyde Street
Leeds
LS2 9LH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/10/2022: Trial's existence confirmed by the HRA.
