Phase 1 trial HMR code: 23-001
| ISRCTN | ISRCTN15245786 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15245786 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1008009 |
| Protocol serial number | IRAS 1008009; HMR code: 23-001; Sponsor code: MED-TSN-101 |
| Sponsor | Medherant Limited |
| Funder | Medherant Limited |
- Submission date
- 08/08/2023
- Registration date
- 18/08/2023
- Last edited
- 17/07/2025
- Recruitment status
- No longer 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
| Primary study design | Interventional |
|---|---|
| Study design | Safety and pharmacokinetics trial in up to 48 healthy women |
| Secondary study design | Open-label |
| Study type | Participant information sheet |
| 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 |
| 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 | 30/03/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 70 Years |
| Sex | Female |
| Target sample size at registration | 48 |
| 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
- United Kingdom
- England
Study participating centre
London
NW10 7EW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
