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 designPhase I pharmacokinetics trial in up to 68 healthy postmenopausal participants
Primary study designInterventional
Secondary study designRandomized, open-label, crossover trial
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format
Scientific titlePhase I trial HMR code: 25-004 [The full scientific title will be published within 30 months after the end of the trial]
Study objectivesThe 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) studiedHealthy volunteers
InterventionThe 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 typeDrug
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.
PhasePhase 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 measureThe 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 measuresThe 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 date23/06/2025
Completion date30/07/2026

Eligibility

Participant type(s)Healthy volunteer
Age groupMixed
SexFemale
Target number of participantsUp to 68
Key inclusion criteriaHealthy human volunteer
Key exclusion criteriaThe 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 enrolment03/09/2025
Date of final enrolment30/04/2026

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 date30/10/2028
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planFull 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 planThe 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.