Phase 1 Trial: RD 792.34234 (SPON1896-22)

ISRCTN	ISRCTN81436702
DOI	https://doi.org/10.1186/ISRCTN81436702
EudraCT/CTIS number	2022-002562-33
IRAS number	1006242
Secondary identifying numbers	SPON1896-22, IRAS 1006242

Submission date: 23/01/2023
Registration date: 24/01/2023
Last edited: 24/01/2023

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

Mrs MDI Neuroscience Portfolio Manager
Scientific

Cardiff University
Medicines Discovery Institute
Main Building
Park Place
Cardiff
CF10 3AT
United Kingdom

Phone	+ 44 (0)2922 511 095
Email	swettenhamj@cardiff.ac.uk

Mrs MDI Neuroscience Portfolio Manager
Public

Cardiff University
Medicines Discovery Institute
Main Building
Park Place
Cardiff
CF10 3AT
United Kingdom

Phone	+ 44 (0)2922 511 095
Email	swettenhamj@cardiff.ac.uk

Dr Annelize Koch
Principal Investigator

Simbec-Orion Clinical Pharmacology
Merthyr Tydfil Industrial Park
Cardiff Road
Merthyr Tydfil
CF48 4DR
United Kingdom

Phone	+44 (0)1443694313
Email	annelize.koch@simbecorion.com

Study information

Study design	A three-part first-in-human trial in up to 116 healthy participants
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Other
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
Scientific title	Phase 1 Trial: RD 792.34234 (SPON1896-22) [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)	1. Approved 06/12/2022, Wales Research Ethics Committee 1 (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)2920 230457; Wales.REC1@wales.nhs.uk), ref: 22/WA/0320 2. Approved 22/12/2022, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, UK; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 21323/0056/001-0001 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	20/06/2022
Completion date	03/11/2023

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	116
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	09/01/2023
Date of final enrolment	29/09/2023

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Simbec Research Limited

Simbec House Merthyr Tydfil Industrial Park
Merthyr Tydfil Industrial Park
Pentrebach
Merthyr Tydfil
Mid Glamorgan
CF48 4DR
United Kingdom

Sponsor information

Cardiff University
University/education

Research Integrity, Governance and Ethics (RIGE) Team Research and Innovation Services
Cardiff Joint Research Office
2nd Floor, Lakeside Building
University Hospital of Wales
Cardiff
CF14 4XW
Wales
United Kingdom

Phone	+44 (0)29 208 79130
Email	resgov@cardiff.ac.uk
Website	https://www.cardiff.ac.uk/medicines-discovery
"ROR"	https://ror.org/03kk7td41

Funders

Funder type

Charity

Wellcome Trust
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Wellcome, WT
Location: United Kingdom

Results and Publications

Intention to publish date	04/04/2025
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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			28/06/2023	No	No

Editorial Notes

24/01/2023: Trial's existence confirmed by the MHRA.