Phase I trial, Quotient code: QSC301137, Sponsor code: LMNL6511C1001
| ISRCTN | ISRCTN46791858 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46791858 |
| IRAS number | 1008478 |
| Secondary identifying numbers | IRAS 1008478; Quotient code: QSC301137, Sponsor code: LMNL6511C1001 |
- Submission date
- 26/10/2023
- Registration date
- 01/11/2023
- Last edited
- 08/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
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
Principal Investigator
Quotient Sciences Limited
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)330 303 1000 |
|---|---|
| Recruitment@weneedyou.co.uk |
Public, Scientific
Liminal BioSciences Ltd.
Unit 1, Iconix Park
London Road
Sawston
Cambridge
CB22 3EG
United Kingdom
| info@liminalbiosciences.com |
Study information
| Study design | Two-part single-centre randomized study to assess pharmacokinetics, safety and tolerability in 88 healthy volunteers |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Other |
| Participant information sheet | Not available in web format |
| Scientific title | Phase I trial, Quotient code: QSC301137 [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 01/12/2023, South Central – Berkshire Research Ethics Committee (Bristol HRA Centre, Temple Quay House, 2 The Square, Temple Quay, Bristol, BS1 6PN, United Kingdom; +44 (0)207 104 8178; berkshire.rec@hra.nhs.uk), ref: 23/SC/0264 2. Approved 01/12/2023, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 46871/0003/001-0001 |
| Condition | 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 | 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) | Pharmacokinetic |
| 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 | 02/10/2023 |
| Overall study end date | 23/07/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 88 |
| Participant 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. |
| 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 | 06/12/2023 |
| Recruitment end date | 23/07/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
Sponsor information
Industry
Unit 1, Iconix Park
London Road
Sawston
Cambridge
CB22 3EG
England
United Kingdom
| info@liminalbiosciences.com | |
| Website | https://liminalbiosciences.com/ |
"ROR" |
https://ror.org/00vvx9s89 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 24/01/2027 |
|---|---|
| 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 highly commercial sensitivity of this Phase I study and the negligible benefit to the public of Phase I information. Results may 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
08/01/2025: Contact and sponsor details updated.
07/12/2023: Ethics approval details added.
02/11/2023: Contact details corrected.
01/11/2023: Trial's existence confirmed by MHRA
