Phase I trial: Fortrea code: 8476207

ISRCTN	ISRCTN88307799
DOI	https://doi.org/10.1186/ISRCTN88307799
IRAS number	1005119
Secondary identifying numbers	IRAS 1005119, Fortrea code: 8476207

Submission date: 17/10/2023
Registration date: 18/10/2023
Last edited: 22/11/2023

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

The HRA has approved deferral of publication of trial details. The full details will be added to the study record within 30 months after the trial has ended.

Contact information

Dr Jim Bush
Principal Investigator

VP CPS Medical Services, Springfield House, Hyde Street
Leeds
LS2 9LH
United Kingdom

ORCID ID	0000-0002-6645-7041
Phone	+44 (0)1133013656
Email	jim.bush@fortrea.com

Mrs Clinical trial scientific and public contact
Public, Scientific

Vifor (International) Inc.
Rechenstrasse 37
St. Gallen
CH-9014
Switzerland

Phone	+41 58 851 80 00
Email	clinicaltrials@cslbehring.com

Study information

Study design	AME study in 8 adult healthy volunteers
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Other
Study type	Treatment
Participant information sheet	No participant information sheet available
Scientific title	Phase I trial: Fortrea code: 8476207 [The full scientific title will be published within 30 months after the end of the trial]
Study hypothesis	The HRA has approved deferral of publication of trial details. The full details will be added to the study record within 30 months after the trial has ended.
Ethics approval(s)	1. Approved 26/08/2022, Harrow Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0) 207 104 8154; harrow.rec@hra.nhs.uk), ref: 22/FT0087 2. Approved 30/08/2022, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 (0) 20 3080 6000; info@mhra.gov.uk), ref: CTA 13739/0212/001-0001
Condition	Healthy volunteers
Intervention	The HRA has approved deferral of publication of trial details. 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)	absorption, metabolism, excretion
Phase	Phase I
Drug / device / biological / vaccine name(s)	The HRA has approved deferral of publication of trial details. The full details will be added to the study record within 30 months after the trial has ended.
Primary outcome measure	The HRA has approved deferral of publication of trial details. The full details will be added to the study record within 30 months after the trial has ended.
Secondary outcome measures	The HRA has approved deferral of publication of trial details. The full details will be added to the study record within 30 months after the trial has ended.
Overall study start date	18/06/2022
Overall study end date	15/12/2022

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Male
Target number of participants	8
Participant inclusion criteria	The HRA has approved deferral of publication of trial details. The full details will be added to the study record within 30 months after the trial has ended.
Participant exclusion criteria	The HRA has approved deferral of publication of trial details. The full details will be added to the study record within 30 months after the trial has ended.
Recruitment start date	31/10/2022
Recruitment end date	15/12/2022

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Fortrea (formerly: Labcorp) Clinical Research Unit [CRU] Limited

Springfield House, Hyde Street
Leeds
LS2 9LH
United Kingdom

Sponsor information

Vifor (International) Inc.
Industry

Rechenstrasse 37
St. Gallen
CH-9014
Switzerland

Phone	+41 58 851 80 00
Email	graclinicalsupport@viforpharma.com

Funders

Funder type

Industry

Vifor (International) Inc.

No information available

Results and Publications

Intention to publish date	16/06/2025
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 analyzed 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 nontherapeutic clinical trials.

Editorial Notes

22/11/2023: A contact email address was changed.
18/10/2023: Trial's existence confirmed by MHRA.