Phase I trial: Labcorp Drug Development Study: 8479217

ISRCTN	ISRCTN14340698
DOI	https://doi.org/10.1186/ISRCTN14340698
EudraCT/CTIS number	2021‐005631‐24
IRAS number	1004924
Secondary identifying numbers	IRAS 1004924, Labcorp Drug Development Study 8479217

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

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 Ashley Brooks
Principal Investigator

Labcorp Clinical Research Unit
Springfield House, Hyde Street
Leeds
LS2 9LH
United Kingdom

Phone	+44 (0)113 301 3521
Email	ashley.brooks@labcorp.com

Dr Ashley Brooks
Scientific

Labcorp Clinical Research Unit
Springfield House, Hyde Street
Leeds
LS2 9LH
United Kingdom

Phone	+44 (0) 113 301 3521
Email	ashley.brooks@labcorp.com

Dr Ashley Brooks
Public

Labcorp Clinical Research Unit
Springfield House, Hyde Street
Leeds
LS2 9LH
United Kingdom

Phone	+44 (0) 113 301 3521
Email	ashley.brooks@labcorp.com

Study information

Study design	A mass balance study and metabolic profile investigation
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Other
Study type	Other
Participant information sheet	Not available in web format
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 hypothesis	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.
Condition	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
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	16/05/2022
Overall study end date	16/09/2022

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	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.
Participant 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.
Participant 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.
Recruitment start date	02/08/2022
Recruitment end date	16/09/2022

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Labcorp Clinical Research Unit Limited

Springfield House
Hyde Street
Leeds
LS2 9LH
United Kingdom

Sponsor information

Bergenbio ASA
Industry

Jonas Lies vei 91
Bergen
5009
Norway

Phone	+44 (0)7810 575 037
Email	post@bergenbio.com

Funders

Funder type

Industry

Bergenbio ASA

No information available

Results and Publications

Intention to publish date	16/03/2025
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	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			28/06/2023	No	No

Editorial Notes

14/10/2022: Trial's existence confirmed by the HRA.