Phase I trial, Quotient Code: QSC208063
| ISRCTN | ISRCTN17473850 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17473850 |
| IRAS number | 1007844 |
| Secondary identifying numbers | IRAS 1007844 |
- Submission date
- 20/07/2023
- Registration date
- 11/08/2023
- Last edited
- 11/08/2023
- 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
Quotient Sciences Limited
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)330 303 1000 |
|---|---|
| Recruitment@weneedyou.co.uk |
Scientific
Quotient Sciences Limited
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)330 303 1000 |
|---|---|
| Recruitment@weneedyou.co.uk |
Public
Quotient Sciences Limited
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)1159749000 |
|---|---|
| regulatory.affairs@quotientsciences.com |
Study information
| Study design | Three-part single-centre randomized study to assess pharmacokinetics, relative bioavailability, safety and tolerability in 72 healthy volunteers |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Other |
| Participant information sheet | Not available in web format |
| Scientific title | Phase I trial, Quotient Code: QSC208063 [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) |
Submitted 21/06/2023, HSC REC B (c/o Office for Research Ethics Committees in Northern Ireland (ORECNI), Business Services Organisation, Lissue Industrial Estate West, Lisburn, Co. Antrim, BT28 2RF, United Kingdom; +44 (0)28 95361400; RECB@hscni.net), ref: 23/NI/0085 |
| Ethics approval additional information | Submitted 21/06/2023, MHRA (10 South Colonnade, Canary Wharf, London E14 4PU, UK; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 42285/0004/001-0001 |
| 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) | Pharmacokinetic |
| 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 | 21/06/2023 |
| Completion date | 29/12/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 72 |
| 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 | 04/09/2023 |
| Date of final enrolment | 29/12/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
Sponsor information
Industry
955 Chesterbrook Blvd. Suite 110
Chesterbrook
PA 19087
United States of America
| Phone | +1 (0)610 354 8840 |
|---|---|
| mdemitrack@trevena.com | |
| Website | https://www.trevena.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 29/06/2027 |
|---|---|
| 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 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 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
28/07/2023: Study's existence confirmed by the MHRA.
