Pharmacokinetic study to the open-label Phase of NUC-5/primary sclerosing cholangitis study

ISRCTN	ISRCTN65190051
DOI	https://doi.org/10.1186/ISRCTN65190051
EudraCT/CTIS number	2022-000261-40, 2023-507027-37
IRAS number	1008879
Secondary identifying numbers	58477

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

Mindelsohn Way
Birmingham
B15 2TT
United Kingdom

Phone	+44 (0)121 371 8173
Email	Palak.Trivedi@uhb.nhs.uk

Dr Falk Pharma
Scientific

Leinenweberstrasse 5
Freiburg
79108
Germany

Phone	+49 (0)76115140
Email	clinical.studies@drfalkpharma.de

Dr GKM Gesellschaft fuer Therapieforschung mbH
Public

Lessingstrasse 14
Munich
80336
Germany

Phone	+49 (0)892091200
Email	nuc-11@gkm-therapieforschung.de

Study information

Study design	Interventional pharmacokinetic study
Primary study design	Interventional
Secondary study design	Pharmacokinetic study
Study setting(s)	Hospital
Study type	Safety
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
Pharmaceutical study type(s)	Pharmacokinetic
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	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.
Secondary outcome measures	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.
Overall study start date	01/07/2023
Completion date	31/12/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

England
United Kingdom

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

Royal Free Hospital

Liver Transplantation
Pond Street
London
NW3 2QG
United Kingdom

Sponsor information

Dr Falk Pharma (Germany)
Industry

Leinenweberstrasse 5
Freiburg
79108
Germany

Phone	+49 (0)76115140
Email	clinical.studies@drfalkpharma.de
Website	https://www.drfalkpharma.de/
"ROR"	https://ror.org/05sh9vm75

Funders

Funder type

Industry

Dr. Falk Pharma
Private sector organisation / For-profit companies (industry)

Alternative name(s): Falk Pharma, Dr Falk Pharma, Dr Falk Pharma GmbH, Dr. Falk Pharma GmbH, Dr. Falk Pharma UK Ltd
Location: United Kingdom

Results and Publications

Intention to publish date	31/01/2026
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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 may be posted on or after the date of publication of full trial details.
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.