Phase I Trial Quotient code: QSC302573
| ISRCTN | ISRCTN12823680 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12823680 |
| IRAS number | 1009846 |
| Secondary identifying numbers | IRAS 1009846, QSC302573 |
- Submission date
- 11/10/2024
- Registration date
- 15/10/2024
- Last edited
- 08/05/2025
- 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. The full details will be added to the study record within 30 months after the trial has ended.
Contact information
Public, Scientific, Principal Investigator
Mere Way, Ruddington Fields, Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0) 330 303 1000 |
|---|---|
| recruitment@weneedyou.co.uk |
Public
United States
Princeton
20850
United States of America
| Phone | +1 844-687-8522 |
|---|---|
| OtsukaUS@druginfo.com |
Study information
| Study design | Relative bioavailability and food effect study in 48 healthy volunteers |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Safety |
| Participant information sheet | Not available in web format. |
| Scientific title | Phase I Trial Quotient code: QSC302573 [the full scientific title will be published within 30 months after the end of the trial] |
| Study objectives | 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) |
Approved 13/09/2024, Wales Research Ethics Committee 2 (Health and Care Research Wales, Castlebridge 5, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 (0) 29 2294 1119; Wales.REC2@wales.nhs.uk), ref: 24/WA/0169 |
| 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. 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) | Relative Bioavailability, Food Effect |
| 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 | 02/07/2024 |
| Completion date | 22/04/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 48 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 24/10/2024 |
| Date of final enrolment | 23/04/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Nottingham
NG116JS
United Kingdom
Sponsor information
Industry
2440 Research Boulevard
Rockville, Maryland
20850
United States of America
| Phone | +1 301-990-0030 |
|---|---|
| expandedaccess@otsuka-us.com | |
| Website | https://www.otsuka-us.com/ |
"ROR" |
https://ror.org/00ew4na22 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 23/10/2027 |
|---|---|
| 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 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 full trial details. |
| IPD sharing plan | The datasets generated during 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
08/05/2025: The overall end date was changed from 23/04/2025 to 22/04/2025.
15/10/2024: Study's existence confirmed by Health Research Authority (HRA) (UK).
