Phase I Trial Quotient code: QSC302573
| ISRCTN | ISRCTN12823680 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12823680 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1009846 |
| Protocol serial number | IRAS 1009846, QSC302573 |
| Sponsor | Otsuka (United States) |
| Funder | Otsuka Pharmaceuticals |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Relative bioavailability and food effect study in 48 healthy volunteers |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| 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 |
| 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(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. |
| 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. The full details will be added to the study record within 30 months after the trial has ended. |
| Completion date | 22/04/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Nottingham
NG116JS
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 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. |
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
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).
