Phase I Trial: Quotient Code QSC303217
| ISRCTN | ISRCTN11329248 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11329248 |
| IRAS number | 1011885 |
| Secondary identifying numbers | Sponsor Code: AVK-101-102, Quotient Code: QSC303217 |
- Submission date
- 24/06/2025
- Registration date
- 01/07/2025
- Last edited
- 01/07/2025
- Recruitment status
- 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 of protocol
The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. Full details will be added to the study record within 30 months after the trial has ended.
Contact information
Dr Terrie Kellmeyer
Public, Scientific
Public, Scientific
Aardvark Therapeutics, Inc., 4370 La Jolla Village Drive, Suite 1050
San Diego
92122
United States of America
| Phone | +1 (858) 225-7696 |
|---|---|
| Info@AardvarkTherapeutics.com |
Dr David Everton
Principal Investigator
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 |
Study information
| Study design | Two-part single-centre mass balance recovery and food effect study in healthy volunteers |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Partially randomised study |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Phase I Trial: Quotient Code QSC303217 |
| Study objectives | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. Full details will be added to the study record within 30 months after the trial has ended. |
| Ethics approval(s) |
Approved 19/06/2025, London – Hampstead Regulatory Ethics Committee (REC) (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)20 7104 8171; hampstead.rec@hra.nhs.uk), ref: 25/LO/0198 |
| Health condition(s) or problem(s) studied | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. 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. 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. 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. 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. Full details will be added to the study record within 30 months after the trial has ended. |
| Overall study start date | 30/04/2025 |
| Completion date | 22/08/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. Full details will be added to the study record within 30 months after the trial has ended. |
| Key exclusion criteria | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. Full details will be added to the study record within 30 months after the trial has ended. |
| Date of first enrolment | 01/07/2025 |
| Date of final enrolment | 22/08/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Quotient Sciences Limited
Mere Way, Ruddington Fields, Ruddington
Nottingham
NG11 6JS
United Kingdom
Nottingham
NG11 6JS
United Kingdom
Sponsor information
Aardvark Therapeutics, Inc.
Industry
Industry
4370 La Jolla Village Drive
Suite 1050
San Diego
92122
United States of America
| Phone | +1 (858) 225-7696 |
|---|---|
| Info@AardvarkTherapeutics.com |
Funders
Funder type
Industry
Aardvark Therapeutics, Inc.
No information available
Results and Publications
| Intention to publish date | 22/02/2028 |
|---|---|
| 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 of the trial details is deferred because of the high 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 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
24/06/2025: Trial's existence confirmed by MHRA.
