Phase 1 trial, HMR code: 21-004
| ISRCTN | ISRCTN12926361 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12926361 |
| EudraCT/CTIS number | 2021-001912-26 |
| IRAS number | 1003759 |
| Secondary identifying numbers | IRAS 1003759, HMR code 21-004 |
- Submission date
- 09/03/2022
- Registration date
- 24/03/2022
- Last edited
- 24/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Not Specified
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record when the results are published, which will be within 30 months after the trial has ended.
Contact information
Dr Denisa Wilkes
Scientific
Scientific
Hammersmith Medicines Research
Cumberland Avenue
London
NW10 7EW
United Kingdom
| Phone | +44 20 8961 4130 |
|---|---|
| rec@hmrlondon.com |
Study information
| Study design | First-in-human safety tolerability and pharmacokinetics trial in up to 104 healthy men |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Part A – double-blind, placebo-controlled, parallel group; Part B – open-label, 2-way crossover assessment of the effect of food |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Phase 1 trial, HMR code: 21-004 The full scientific title will be published within 30 months after the end of the trial |
| Study hypothesis | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record when the results are published, which will be within 30 months after the trial has ended. |
| Ethics approval(s) | 1. Approved 29/06/2021, Health and Social Care Research Ethics Committee B (HSC REC B, Unit 4, Lissue Industrial Estate West, Rathdown Walk, Moira Road, Lisburn, BT28 2RF, UK; +44 28 95361400; recb@hscni.net), ref: 21/NI/0069 2. Approved 15/07/2021, MHRA (10 South Colonnade, Canary Wharf, London E14 4PU, UK; +44 20 3080 6000; info@mhra.gov.uk), ref: none provided The HRA has approved deferral of publication of trial details. |
| Condition | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record when the results are published, which will be within 30 months after the trial has ended. |
| Intervention | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record when the results are published, which will be within 30 months after the trial has ended. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record when the results are published, which will be within 30 months after the trial has ended. |
| Primary outcome measure | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record when the results are published, which will be within 30 months after the trial has ended. |
| Secondary outcome measures | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record when the results are published, which will be within 30 months after the trial has ended. |
| Overall study start date | 27/05/2021 |
| Overall study end date | 30/11/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | Up to 104 |
| Participant inclusion criteria | Healthy human volunteer |
| Participant exclusion criteria | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record when the results are published, which will be within 30 months after the trial has ended. |
| Recruitment start date | 09/08/2021 |
| Recruitment end date | 30/08/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Hammersmith Medicines Research Limited
Cumberland Avenue
London
NW10 7EW
United Kingdom
London
NW10 7EW
United Kingdom
Sponsor information
Gedeon Richter Plc
Industry
Industry
Gyömrői út 19-21
Budapest
H-1103
Hungary
| Phone | +36 1-431-4000 |
|---|---|
| ra.ctarichter@richter.hu |
Funders
Funder type
Industry
Gedeon Richter Plc
No information available
Results and Publications
| Intention to publish date | 30/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Trial information and summary results 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. |
| 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
24/03/2022: Trial's existence confirmed by Health and Social Care Research Ethics Committee B.
