Phase 1 trial: Labcorp code 8501022

ISRCTN	ISRCTN13265717
DOI	https://doi.org/10.1186/ISRCTN13265717
IRAS number	1006499
Secondary identifying numbers	IRAS 1006499, Labcorp code: 8501022

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Firas Almazedi
Principal Investigator

Drapers Yard
Marshall Street
Holbeck
Leeds
LS11 9EH
United Kingdom

Phone	+44 (0)113 301 3642
Email	firas.almazedi@labcorp.com

Dr Firas Almazedi
Public

Drapers Yard
Marshall Street
Holbeck
Leeds
LS11 9EH
United Kingdom

Phone	+44 (0)113 301 3642
Email	firas.almazedi@labcorp.com

Dr Firas Almazedi
Scientific

Drapers Yard
Marshall Street
Holbeck
Leeds
LS11 9EH
United Kingdom

Phone	+44 (0)113 301 3642
Email	firas.almazedi@labcorp.com

Study information

Study design	Safety and tolerability study in 108 healthy volunteers.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Pharmaceutical testing facility
Study type	Other
Participant information sheet	Not available in web format, please use the contact details to request a 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
Pharmaceutical study type(s)
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	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.
Secondary outcome measures	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.
Overall study start date	23/09/2022
Completion date	26/09/2023

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centres

Labcorp CRU Ltd

Springfield House
Hyde Street
Leeds
LS2 9LH
United Kingdom

Labcorp CRU Ltd

Drapers Yard, Marshall Street
Holbeck
Leeds
LS11 9EH
United Kingdom

Sponsor information

Albireo (Sweden)
Industry

Arvid Wallgrens backe 20
Göteborg
41346
Sweden

Phone	+46 31 741 14 80
Email	medinfo@albireopharma.com
Website	https://albireopharma.com/
"ROR"	https://ror.org/02py10784

Funders

Funder type

Industry

Albireo AB

No information available

Results and Publications

Intention to publish date	04/04/2026
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Full trial details will be published up to 30 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 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

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).