Phase I trial HMR code: 25-004

ISRCTN	ISRCTN60121726
DOI	https://doi.org/10.1186/ISRCTN60121726
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	1012103
Protocol serial number	IRAS 1012103; HMR code: 25-004
Sponsor	Besins Healthcare Ireland Ltd
Funder	Besins Healthcare Ireland Ltd

Submission date: 15/08/2025
Registration date: 02/09/2025
Last edited: 20/11/2025

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 sponsor has confirmed that the trial meets the criteria for 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 Takahiro Yamamoto
Principal investigator

Hammersmith Medicines Research
Cumberland Avenue
Park Royal
London
NW10 7EW
United Kingdom

Phone	+44 (0)20 8961 4130
Email	rec@hmrlondon.com

Dr Clinical Operations Department
Scientific

Besins Healthcare Ireland Ltd.
Level 4, Plaza 4
Custom House Plaza
International Financial Services Centre
Harbourmaster Place
Dublin 1
Dublin
D01 A9N3
Ireland

Phone	+353 871039215
Email	clinicaloperations@besins-healthcare.com

Dr Clinical Operations Department
Public

Besins Healthcare Ireland Ltd
Level 4, Plaza 4
Custom House Plaza
International Financial Services Centre
Harbourmaster Place
Dublin 1
Dublin
D01 A9N3
Ireland

Phone	+353 871039215
Email	clinicaloperations@besins-healthcare.com

Study information

Primary study design	Interventional
Study design	Phase I pharmacokinetics trial in up to 68 healthy postmenopausal participants
Secondary study design	Randomized, open-label, crossover trial
Scientific title	Phase I trial HMR code: 25-004 [The full scientific title will be published within 30 months after the end of the trial]
Study objectives	The sponsor has confirmed that the trial meets the criteria for 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 05/08/2025, London – Brent Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)20 71048128; brent.rec@hra.nhs.uk), ref: 25/LO/0420
Health condition(s) or problem(s) studied	Healthy volunteers
Intervention	The sponsor has confirmed that the trial meets the criteria for 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
Phase	Phase I
Drug / device / biological / vaccine name(s)	The sponsor has confirmed that the trial meets the criteria for 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)	The sponsor has confirmed that the trial meets the criteria for 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)	The sponsor has confirmed that the trial meets the criteria for 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.
Completion date	30/07/2026

Eligibility

Participant type(s)	Healthy volunteer
Age group	Mixed
Sex	Female
Target sample size at registration	68
Key inclusion criteria	Healthy human volunteer
Key exclusion criteria	The sponsor has confirmed that the trial meets the criteria for 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	03/09/2025
Date of final enrolment	30/04/2026

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Hammersmith Medicines Research (HMR)

Cumberland Avenue, Park Royal
London
NW10 7EW
England

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

20/11/2025: Internal review.
29/08/2025: Study's existence confirmed by the MHRA.