Phase 1 trial HMR code: 23-001
| ISRCTN | ISRCTN15245786 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15245786 |
| IRAS number | 1008009 |
| Secondary identifying numbers | IRAS 1008009; HMR code: 23-001; Sponsor code: MED-TSN-101 |
- Submission date
- 08/08/2023
- Registration date
- 18/08/2023
- Last edited
- 17/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Deferred
- Condition category
- Other
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
Principal Investigator
Hammersmith Medicines Research Limited
Cumberland Avenue
Park Royal
London
NW10 7EW
United Kingdom
| Phone | +44 20 8961 4130 |
|---|---|
| rec@hmrlondon.com |
Scientific
Medherant Limited
The Venture Centre Sir William Lyons Road
University of Warwick Science Park
Coventry
CV4 7EZ
United Kingdom
| Phone | +44 2476 323 060 |
|---|---|
| j.burt@medherant.co.uk |
Scientific
Medherant Limited
The Venture Centre Sir William Lyons Road
University of Warwick Science Park
Coventry
CV4 7EZ
United Kingdom
| Phone | +44 2476 323 060 |
|---|---|
| g.clark@medherant.co.uk |
Study information
| Study design | Safety and pharmacokinetics trial in up to 48 healthy women |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Open-label |
| Study setting(s) | Pharmaceutical testing facility, Other |
| Study type | Other, Safety |
| Participant information sheet | Not available in web format |
| Scientific title | Phase 1 trial HMR code: 23-001 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) |
1. Approved 24/09/2023, North East – York Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 (0) 207 104 8052; york.rec@hra.nhs.uk), ref: 23/NE/0096 2. Approved 27/09/2023, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 20 3080 6000; info@mhra.gov.uk), ref: CTA 52692/0001/001-0001 |
| 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 | 23/06/2023 |
| Completion date | 30/03/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 70 Years |
| Sex | Female |
| Target number of participants | Minimum of 36 and up to 48 healthy post menopausal women |
| Key inclusion 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. |
| 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 | 25/09/2023 |
| Date of final enrolment | 19/09/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
NW10 7EW
United Kingdom
Sponsor information
Industry
The Venture Centre Sir William Lyons Road
University of Warwick Science Park
Coventry
CV4 7EZ
England
United Kingdom
| Phone | +44 2476 323 060 |
|---|---|
| g.clark@medherant.co.uk |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 04/12/2027 |
|---|---|
| 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 1 study and the negligible benefit to the public of phase 1 information. Results will 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
17/07/2025: The following changes were made to the study record:
1. The study design was changed from 'Safety and pharmacokinetics trial in up to 24 healthy women' to 'Safety and pharmacokinetics trial in up to 48 healthy women'.
2. The target number of participants was changed from 'Up to 48' to 'Minimum of 36 and up to 48 healthy post-menopausal women'.
3. Age limits added.
4. The date of final enrolment was changed from 22/07/2025 to 19/09/2025.
5. The completion date was changed from 19/09/2025 to 30/03/2026.
25/06/2025: The following changes were made to the trial record:
1. The overall end date was changed from 04/03/2024 to 19/09/2025.
2. The target number of participants was changed from 24 to 48.
3. The recruitment end date was changed from 04/12/2023 to 22/07/2025.
04/10/2023: The ethics approvals were added.
18/08/2023: Trial's existence confirmed by MHRA.
