Phase 1 trial: Labcorp code 8501022
| ISRCTN | ISRCTN13265717 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13265717 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1006499 |
| Protocol serial number | IRAS 1006499, Labcorp code: 8501022 |
| Sponsor | Albireo (Sweden) |
| Funder | Albireo AB |
- Submission date
- 21/03/2023
- Registration date
- 23/03/2023
- Last edited
- 30/10/2023
- 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
Drapers Yard
Marshall Street
Holbeck
Leeds
LS11 9EH
United Kingdom
| Phone | +44 (0)113 301 3642 |
|---|---|
| firas.almazedi@labcorp.com |
Public
Drapers Yard
Marshall Street
Holbeck
Leeds
LS11 9EH
United Kingdom
| Phone | +44 (0)113 301 3642 |
|---|---|
| firas.almazedi@labcorp.com |
Scientific
Drapers Yard
Marshall Street
Holbeck
Leeds
LS11 9EH
United Kingdom
| Phone | +44 (0)113 301 3642 |
|---|---|
| firas.almazedi@labcorp.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Safety and tolerability study in 108 healthy volunteers. |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Phase 1 trial: Labcorp code 8501022 |
| 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) | 1. Approved 21/12/2022, North East - York Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0) 207 104 8079; york.rec@hra.nhs.uk), ref: 22/NE/0185 2. Approved 17/01/2023, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, UK; +44 (0) 20 3080 6000; info@mhra.gov.uk), ref: CTA 36216/0012/001-0001 The HRA has approved deferral of publication of trial details. |
| Health condition(s) or problem(s) studied | Healthy volunteers |
| 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 | 26/09/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 108 |
| Total final enrolment | 76 |
| 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 | 06/02/2023 |
| Date of final enrolment | 26/09/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Hyde Street
Leeds
LS2 9LH
United Kingdom
Holbeck
Leeds
LS11 9EH
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 | 26/07/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/10/2023: The following changes were made:
1. The overall study end date was changed from 04/10/2023 to 26/09/2023.
2. Total final enrolment was added.
3. The recruitment end date was changed from 04/10/2023 to 26/09/2023.
22/03/2023: Trial's existence confirmed by the Health Research Authority (HRA) (UK).
