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.
Study website
Contact information
Type
Scientific
Contact name
Dr Christophe Pompon
ORCID ID
Contact details
Theravia
16 rue Montrosier
Neuilly-Sur-Seine
92200
France
-
Christophe.pompon@theravia.com
Type
Public
Contact name
Ms Laura Thomas-Bourgneuf
ORCID ID
Contact details
Theravia
16 rue Montrosier
Neuilly-Sur-Seine
92200
France
+33 (0)6 50 63 93 63
laura.thomas-bourgneuf@theravia.com
Type
Principal Investigator
Contact name
Dr Annelize Koch
ORCID ID
Contact details
Simbec-Orion Clinical Pharmacology
Merthyr Tydfil Industrial Park
Cardiff Road
Merthyr Tydfil
CF48 4DR
United Kingdom
+44 (0)1443694313
annelize.koch@simbecorion.com
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
1008056
ClinicalTrials.gov number
Nil known
Protocol/serial number
ADR-UK-23-1, IRAS 1008056
Study information
Scientific title
Phase I Trial: RD 785.35736 (ADR-UK-23-1)
Acronym
ADR-UK-23-1
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 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
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
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Overall study end date
23/11/2024
Reason abandoned (if study stopped)
Eligibility
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 type(s)
Healthy volunteer
Age group
Adult
Lower age limit
18 Years
Upper age limit
60 Years
Sex
Both
Target number of participants
90
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
30/04/2024
Recruitment end date
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
Organisation
Theravia
Sponsor details
16 rue Montrosier
Neuilly-Sur-Seine
92200
France
-
question@theravia.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Theravia
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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.
Intention to publish date
23/05/2027
Individual participant data (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.
IPD sharing plan summary
Not expected to be made available
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|