Phase 1 trial HMR code: 22-006
| ISRCTN | ISRCTN34662787 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34662787 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | 2022-001954-47 |
| Integrated Research Application System (IRAS) | 1005897 |
| Protocol serial number | IRAS 1005897, HMR code: 22-006 |
| Sponsor | Heptares Therapeutics (United Kingdom) |
| Funder | Heptares Therapeutics (United Kingdom) |
- 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
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
Scientific
HMR
Cumberland Avenue
London
NW10 7EW
United Kingdom
| Phone | +44 (0)20 8961 4130 |
|---|---|
| rec@hmrlondon.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pharmacokinetic-interaction open-label crossover study |
| Secondary study design | Open-label crossover study |
| Study type | Participant information sheet |
| 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 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 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 |
| 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 | 26/12/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 16 |
| Key inclusion criteria | Healthy human volunteer |
| 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 | 29/07/2022 |
| Date of final enrolment | 25/09/2022 |
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
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.
