Phase I Trial: Quotient Code QSC300687
| ISRCTN | ISRCTN31420409 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31420409 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1008711 |
| Protocol serial number | IRAS 1008711, Quotient Code: QSC300687 |
| Sponsor | Tarsus Pharmaceuticals, Inc. |
| Funder | Tarsus Pharmaceuticals, Inc. |
- Submission date
- 28/05/2024
- Registration date
- 31/05/2024
- Last edited
- 21/06/2024
- 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 trial. The full details will be added to the study record within 30 months after the trial has ended.
Contact information
Principal investigator
Mere Way, Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)330 303 1000 |
|---|---|
| recruitment@weneedyou.co.uk |
Public, Scientific
15440 Laguna Canyon Road, Suite 160
Irvine
CA 92618
United States of America
Public, Scientific
15440 Laguna Canyon Road, Suite 160
Irvine
CA 92618
United States of America
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Mass balance recovery pharmacokinetic metabolite profiling and identification and safety and tolerability study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Phase I Trial: Quotient Code QSC300687 |
| 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) |
Submitted 30/04/2024, London - Surrey Borders REC (Equinox House, City Link, Nottingham, NG2 4LA, United Kingdom; + 44 (0) 20 7104 8057; surreyborders.rec@hra.nhs.uk), ref: 24/LO/0231 |
| 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 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 | 18/01/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 8 |
| 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 | 02/07/2024 |
| Date of final enrolment | 18/01/2025 |
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
21/06/2024: A scientific/public contact was added.
28/05/2024: Trial's existence confirmed by MHRA
