Phase 1 trial, HMR code: 21-004
| ISRCTN | ISRCTN12926361 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12926361 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | 2021-001912-26 |
| Integrated Research Application System (IRAS) | 1003759 |
| Protocol serial number | IRAS 1003759, HMR code 21-004 |
| Sponsor | Gedeon Richter Plc |
| Funder | Gedeon Richter Plc |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | First-in-human safety tolerability and pharmacokinetics trial in up to 104 healthy men |
| 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 type | Participant information sheet |
| 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 objectives | 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. |
| Health condition(s) or problem(s) studied | 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 |
| 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(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. |
| Key secondary outcome measure(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. |
| Completion date | 30/11/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 104 |
| Key inclusion criteria | Healthy human volunteer |
| Key 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. |
| Date of first enrolment | 09/08/2021 |
| Date of final enrolment | 30/08/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Hammersmith Medicines Research Limited
Cumberland Avenue
London
NW10 7EW
United Kingdom
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
24/03/2022: Trial's existence confirmed by Health and Social Care Research Ethics Committee B.
