Phase I trial HMR code: 25-004

ISRCTN	ISRCTN60121726
DOI	https://doi.org/10.1186/ISRCTN60121726
IRAS number	1012103
Secondary identifying numbers	IRAS 1012103; HMR code: 25-004

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

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

Study design	Phase I pharmacokinetics trial in up to 68 healthy postmenopausal participants
Primary study design	Interventional
Secondary study design	Randomized, open-label, crossover trial
Study setting(s)	Other
Study type	Other
Participant information sheet	Not available in web format
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
Pharmaceutical study type(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.
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	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.
Secondary outcome measures	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.
Overall study start date	23/06/2025
Completion date	30/07/2026

Eligibility

Participant type(s)	Healthy volunteer
Age group	Mixed
Sex	Female
Target number of participants	Up to 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

England
United Kingdom

Study participating centre

Hammersmith Medicines Research (HMR)

Cumberland Avenue, Park Royal
London
NW10 7EW
United Kingdom

Sponsor information

Besins Healthcare Ireland Ltd
Industry

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

Funders

Funder type

Industry

Besins Healthcare Ireland Ltd

No information available

Results and Publications

Intention to publish date	30/10/2028
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 may 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

29/08/2025: Study's existence confirmed by the MHRA.