Phase I Trial: Quotient Code QSC300787
| ISRCTN | ISRCTN14891667 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14891667 |
| IRAS number | 1009779 |
| Secondary identifying numbers | IRAS 1009779, Quotient Code: QSC300787 |
- 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
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 study. The full details will be added to the study records within 30 months after the trial has ended.
Contact information
Dr Nand Singh
Principal Investigator
Principal Investigator
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)330 303 1000 |
|---|---|
| recruitment@weneedyou.co.uk |
Mr Clinical Trial Information Desk N/A
Public, Scientific
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
| 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 |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Parts 1 & 2 - non-randomized repeated measures, Part 3 - randomized crossover, Part 4 - non-randomized |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Other, Safety |
| 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 |
| Pharmaceutical study type(s) | Pharmacokinetic, Relative bioavailability, food effect, safety and tolerability study |
| 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 | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 06/05/2024 |
| Completion date | 08/02/2027 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Quotient Sciences Limited
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
Sponsor information
Alumis Inc.
Industry
Industry
280 East Grand Avenue
South San Francisco
CA 94080
United States of America
| Phone | +1 (0)650 231 6625 |
|---|---|
| info@alumis.com |
Funders
Funder type
Industry
Alumis Inc.
No information available
Results and Publications
| Intention to publish date | 08/08/2027 |
|---|---|
| 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 study. Publication of some study 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 will be posted on or after the date of publication of full trial details. |
| 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.
