Phase I Trial: Quotient Code QSC303217
| ISRCTN | ISRCTN11329248 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11329248 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1011885 |
| Protocol serial number | Sponsor Code: AVK-101-102, Quotient Code: QSC303217 |
| Sponsor | Aardvark Therapeutics, Inc. |
| Funder | Aardvark Therapeutics, Inc. |
- Submission date
- 24/06/2025
- Registration date
- 01/07/2025
- Last edited
- 01/07/2025
- 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. Full details will be added to the study record within 30 months after the trial has ended.
Contact information
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 |
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
| Primary study design | Interventional |
|---|---|
| Study design | Two-part single-centre mass balance recovery and food effect study in healthy volunteers |
| Secondary study design | Partially randomised study |
| Study type | 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 |
| 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(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. |
| 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. Full details will be added to the study record within 30 months after the trial has ended. |
| 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 | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Nottingham
NG11 6JS
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
24/06/2025: Trial's existence confirmed by MHRA.
