Pharmacokinetic study to the open-label Phase of NUC-5/primary sclerosing cholangitis study
| ISRCTN | ISRCTN65190051 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65190051 |
| Clinical Trials Information System (CTIS) | 2022-000261-40, 2023-507027-37 |
| Integrated Research Application System (IRAS) | 1008879 |
| Protocol serial number | 58477 |
| Sponsor | Dr Falk Pharma (Germany) |
| Funder | Dr. Falk Pharma |
- Submission date
- 31/01/2025
- Registration date
- 17/02/2025
- Last edited
- 17/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
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
Dr Palak Trivedi
Principal investigator
Principal investigator
Mindelsohn Way
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 371 8173 |
|---|---|
| Palak.Trivedi@uhb.nhs.uk |
Dr Falk Pharma
Scientific
Scientific
Leinenweberstrasse 5
Freiburg
79108
Germany
| Phone | +49 (0)76115140 |
|---|---|
| clinical.studies@drfalkpharma.de |
Dr GKM Gesellschaft fuer Therapieforschung mbH
Public
Public
Lessingstrasse 14
Munich
80336
Germany
| Phone | +49 (0)892091200 |
|---|---|
| nuc-11@gkm-therapieforschung.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional pharmacokinetic study |
| Secondary study design | Pharmacokinetic study |
| Scientific title | 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. |
| Study acronym | NUC-11/BIO |
| 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 18/12/2023, West Midlands – Edgbaston Research Ethics Committee (2 Redman Place, Stratford, E20 1 JQ, United Kingdom; +44 (0)207 104 8000; edgbaston.rec@hra.nhs.uk), ref: 23/WM/0230 |
| Health condition(s) or problem(s) studied | 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 | 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 | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion 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. |
| 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 | 16/09/2024 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Queen Elizabeth Hospital Birmingham
University Hospital Birmingham NHS Foundation Trust
Robert Aitken Institute of Clinical Research
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom
Robert Aitken Institute of Clinical Research
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom
Royal Free Hospital
Liver Transplantation
Pond Street
London
NW3 2QG
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
04/02/2025: Study's existence confirmed by the HRA.
