Phase I Trial: 36540 (DF-PK-01)

ISRCTN	ISRCTN69652929
DOI	https://doi.org/10.1186/ISRCTN69652929
Integrated Research Application System (IRAS)	1012899
Sponsor	DF Medical Ventures Limited
Funder	DF Medical Ventures Limited

Submission date: 16/02/2026
Registration date: 16/02/2026
Last edited: 16/02/2026

Recruitment status: 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

Mr Julian Fox
Scientific, Public

DF Medical Ventures Limited, 10 Burton Hills Blvd, Suite 400
Nashville
37215
United States of America

Phone	N/A
Email	jpf@dfmvi.com

Dr Ebenezer Anobah
Principal investigator

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

Phone	+44 (0)1685709504
Email	ebenezer.anobah@simbecorion.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Crossover
Purpose	Device feasibility
Scientific title	Phase I Trial: 36540 (DF-PK-01)
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 18/12/2025, Wales Research Ethics Committee 2 (Health and Care Research Wales, Floor 4, Crown Building, Cathays Park, Cardiff, CF10 3NQ, United Kingdom; +44 (0)2922 941119; Wales.REC2@wales.nhs.uk), ref: 25/WA/0252 2. Approved 22/12/2025, MHRA (MHRA, 10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 61689/0001/001-0001
Health condition(s) or problem(s) studied	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/Device
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(s)	[Outcome name] measured using [metric or method of measurement] at [timepoint(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.
Key secondary outcome measure(s)
Completion date	19/06/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	20 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	36
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	09/01/2026
Date of final enrolment	05/06/2026

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Simbec-Orion Clinical Pharmacology (AKA Simbec Research Ltd)

Simbec-Orion Clinical Pharmacology, Merthyr Tydfil Industrial Park, Cardiff Road
Merthyr Tydfil
CF48 4DR
Wales

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

16/02/2026: Study's existence confirmed by Wales Research Ethics Committee 2.