Phase I Trial: Quotient Code QSC300787
| ISRCTN | ISRCTN14891667 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14891667 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1009779 |
| Protocol serial number | IRAS 1009779, Quotient Code: QSC300787 |
| Sponsor | Alumis Inc. |
| Funder | Alumis Inc. |
- Submission date
- 18/06/2024
- Registration date
- 03/07/2024
- Last edited
- 17/07/2024
- 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 study. The full details will be added to the study records within 30 months after the trial has ended.
Contact information
Principal investigator
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)330 303 1000 |
|---|---|
| recruitment@weneedyou.co.uk |
Public, Scientific
280 East Grand Avenue
South San Francisco
CA 94080
United States of America
| Phone | +1 (0)650 231 6625 |
|---|---|
| info@alumis.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Relative bioavailability, food effect, safety and tolerability study: Parts 1 & 2 - non-randomized repeated measures, Part 3 - randomized crossover, Part 4 - non-randomized |
| Secondary study design | Parts 1 & 2 - non-randomized repeated measures, Part 3 - randomized crossover, Part 4 - non-randomized |
| Scientific title | Phase I Trial: Quotient Code QSC300787 |
| Study objectives | The Sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the study. The full details will be added to the study records within 30 months after the trial has ended. |
| Ethics approval(s) |
Approved 04/07/2024, London – Harrow REC (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8154; harrow.rec@hra.nhs.uk), ref: 24/LO/0336 |
| 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 study. The full details will be added to the study records 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 study. The full details will be added to the study records 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 study. The full details will be added to the study records 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 study. The full details will be added to the study records within 30 months after the trial has ended. |
| Completion date | 08/02/2027 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 84 |
| Key inclusion criteria | The Sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the study. The full details will be added to the study records 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 study. The full details will be added to the study records within 30 months after the trial has ended. |
| Date of first enrolment | 10/07/2024 |
| Date of final enrolment | 08/02/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Ruddington Fields
Ruddington
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 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. |
Editorial Notes
17/07/2024: Contact details updated.
09/07/2024: Ethics approval details added.
25/06/2024: Study's existence confirmed by the MHRA.
