Phase I trial code: PKM17308
| ISRCTN | ISRCTN49135540 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49135540 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1005387 |
| Protocol serial number | IRAS 1005387 |
| Sponsor | Sanofi-Aventis Recherche & Développement |
| Funder | Sanofi-Aventis Recherche & Développement |
- Submission date
- 15/11/2023
- Registration date
- 17/11/2023
- Last edited
- 17/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
Plain English summary of protocol
The Health Research Authority (HRA) has approved 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)115 974 9000 |
|---|---|
| litza.mckenzie@quotientsciences.com |
Public, Scientific
1 Avenue Pierre Brossolette
Chilly-Mazarin
91380
France
| Phone | None provided |
|---|---|
| uk-medicalinformation@sanofi.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pharmacokinetics (PK) study in 12 healthy participants |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Phase I trial code: PKM17308 |
| Study objectives | The Health Research Authority (HRA) has approved 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 10/06/2022, North West - Greater Manchester Central Research Ethics Committee (3rd Floor Barlow House 4 Minshull Street, Manchester, LM1 3DZ, United Kingdom; +44 (0)207 104 8244, (0)207 104 8004; gmcentral.rec@hra.nhs.uk), ref: 22/NW/0258 |
| Health condition(s) or problem(s) studied | Healthy volunteers |
| Intervention | The Health Research Authority (HRA) has approved 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 Health Research Authority (HRA) has approved 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 Health Research Authority (HRA) has approved 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 Health Research Authority (HRA) has approved 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 | 15/06/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 12 |
| Key inclusion criteria | Healthy human volunteer |
| Key exclusion criteria | The Health Research Authority (HRA) has approved 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 | 24/04/2023 |
| Date of final enrolment | 15/06/2023 |
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 | Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org |
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
16/11/2023: Study's existence confirmed by the Medicines and Healthcare products Regulatory Agency (MHRA) (UK).
