Phase I Trial: RD 785.35736 (ADR-UK-23-1)

ISRCTN	ISRCTN40495811
DOI	https://doi.org/10.1186/ISRCTN40495811
IRAS number	1008056
Secondary identifying numbers	ADR-UK-23-1, IRAS 1008056

Submission date: 12/04/2024
Registration date: 12/04/2024
Last edited: 12/04/2024

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.

Study website

Contact information

Dr Christophe Pompon
Scientific

Theravia
16 rue Montrosier
Neuilly-Sur-Seine
92200
France

Email	Christophe.pompon@theravia.com

Ms Laura Thomas-Bourgneuf
Public

Theravia
16 rue Montrosier
Neuilly-Sur-Seine
92200
France

Phone	+33 (0)6 50 63 93 63
Email	laura.thomas-bourgneuf@theravia.com

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	Three-part open-label study in up to 90 healthy participants
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Pharmaceutical testing facility
Study type	Other, Safety
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Phase I Trial: RD 785.35736 (ADR-UK-23-1)
Study acronym	ADR-UK-23-1
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 16/01/2024, Wales Research Ethics Committee 2 (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 (0)2922 941119; Wales.REC2@wales.nhs.uk), ref: 23.WA.0204
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)	Pharmacokinetic
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	10/02/2023
Completion date	23/11/2024

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	Both
Target number of participants	90
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	30/04/2024
Date of final enrolment	17/11/2024

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

Theravia
Industry

16 rue Montrosier
Neuilly-Sur-Seine
92200
France

Email	question@theravia.com
Website	https://theravia.com/

Funders

Funder type

Industry

Theravia

No information available

Results and Publications

Intention to publish date	23/05/2027
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.

Editorial Notes

12/04/2024: Study's existence confirmed by Wales Research Ethics Committee 2.