Phase 1 trial HMR code: 22-006
| ISRCTN | ISRCTN34662787 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34662787 |
| EudraCT/CTIS number | 2022-001954-47 |
| IRAS number | 1005897 |
| Secondary identifying numbers | IRAS 1005897, HMR code: 22-006 |
- Submission date
- 13/07/2022
- Registration date
- 25/07/2022
- Last edited
- 08/02/2023
- Recruitment status
- No longer 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
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 Temitope Fadeke
Scientific
Scientific
HMR
Cumberland Avenue
London
NW10 7EW
United Kingdom
| Phone | +44 (0)20 8961 4130 |
|---|---|
| rec@hmrlondon.com |
Study information
| Study design | Pharmacokinetic-interaction open-label crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Open-label crossover study |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Other |
| Participant information sheet | Not available in web format. |
| Scientific title | Phase 1 trial HMR code: 22-006 The full scientific title will be published within 30 months after the end of the trial |
| Study hypothesis | 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 26/07/2022 London – Brent Research Ethics Committee (80 London Road, Skipton House, SE1 6LH, United Kingdom; +44 (0)207 1048137; brent.rec@hra.nhs.uk), ref: 22/LO/0430 2. Approved 26/07/2022 MHRA (10 South Colonnade, Canary Wharf, London E14 4PU, United Kingdom; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 42719/0013/001-0001 |
| Condition | 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) | |
| 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 | 15/06/2022 |
| Overall study end date | 26/12/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Up to 16 |
| Participant inclusion criteria | Healthy human volunteer |
| Participant 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. |
| Recruitment start date | 29/07/2022 |
| Recruitment end date | 25/09/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
HMR
Cumberland Avenue, Park Royal
London
NW10 7EW
United Kingdom
London
NW10 7EW
United Kingdom
Sponsor information
Heptares Therapeutics (United Kingdom)
Industry
Industry
Steinmetz Building
Granta Park
Cambridge
CB21 6DG
England
United Kingdom
| Phone | +44 (0)1223 949 100 |
|---|---|
| reception@soseiheptares.com | |
| Website | http://www.heptares.com/ |
"ROR" |
https://ror.org/051fk5x88 |
Funders
Funder type
Industry
Heptares Therapeutics (United Kingdom)
No information available
Results and Publications
| Intention to publish date | 26/06/2025 |
|---|---|
| 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
08/02/2023: The study setting has been changed from ‘Other’.
11/08/2022: Ethics approval added.
01/08/2022: The HRA has confirmed that it approved this deferral.
22/07/2022: Trial's existence confirmed by MHRA.
