Friedrich, Christian http://orcid.org/0000-0001-8955-4808
Francke, Klaus
Gashaw, Isabella
Scheerans, Christian
Klein, Stefan
Fels, Lueder
Smith, Jaclyn A. http://orcid.org/0000-0001-8837-4928
Hummel, Thomas
Morice, Alyn http://orcid.org/0000-0002-6135-9610
Clinical trials referenced in this document:
Documents that mention this clinical trial
Mass Balance and Metabolic Pathways of Eliapixant, a P2X3 Receptor Antagonist, in Healthy Male Volunteers
https://doi.org/10.1007/s13318-023-00866-0
Safety, Pharmacodynamics, and Pharmacokinetics of P2X3 Receptor Antagonist Eliapixant (BAY 1817080) in Healthy Subjects: Double-Blind Randomized Study
https://doi.org/10.1007/s40262-022-01126-1
Funding for this research was provided by:
Bayer AG
Article History
Accepted: 30 March 2022
First Online: 28 May 2022
Declarations
:
: This study was funded by Bayer AG. The funder was responsible for the study design, data collection, data analysis, data interpretation, and study report writing. The corresponding author had full access to all data in the study and had final responsibility for the decision to submit this paper for publication.
: Christian Friedrich, Klaus Francke, Christian Scheerans, Stefan Klein, and Lueder Fels are employees of Bayer AG, Berlin, Germany. Isabella Gashaw was an employee of Bayer AG, Berlin, Germany, when the study was planned, conducted, and analyzed. Alyn Morice reports grants, personal fees, non-financial support, and other from Bayer AG, and grants, personal fees, non-financial support, and other from Bayer US, during the conduct of the study; personal fees and non-financial support from AstraZeneca, personal fees, non-financial support, and other from Bellus Health, personal fees and non-financial support from Boehringer Ingelheim, personal fees and non-financial support from Chiesi Ltd, grants, personal fees, and non-financial support from GlaxoSmithKline, grants, personal fees, non-financial support, and other from Merck Sharp & Dohme Corp., grants from Menlo Therapeutics, grants, personal fees, and other from NeRRe Therapeutics, grants, personal fees, and non-financial support from Phillips Respironics, grants, personal fees, and non-financial support from Respivant Sciences, Inc., and grants, personal fees, non-financial support, and other from Sanofi, outside the submitted work. Jaclyn A. Smith reports grants and personal fees from Bayer AG during the conduct of the study, personal fees from Algernon Pharmaceuticals, AstraZeneca, and Boehringer Ingelheim, grants and personal fees from Axalbion, Bellus Health, GlaxoSmithKline, Menlo Therapeutics, Merck Sharp & Dohme Corp., NeRRe Therapeutics, Nocion Therapeutics, and Shionogi Inc., outside the submitted work. The VitaloJAK algorithm has been licensed by Manchester University Foundation Trust and the University of Manchester to Vitalograph Ltd. and Vitalograph Ireland (Ltd.). Manchester University Foundation Trust receives royalties, which may be shared with the clinical division in which Jaclyn A. Smith works. Thomas Hummel reports grants from aspUraclip, Berlin, Germany, Smell and Taste Laboratory, Geneva, Switzerland, Sony, Stuttgart, Germany, and Takasago, Paris, France, and personal fees from Frequency Therapeutics, Farmington, CT, USA and Baiafoods, Madrid, Spain, outside the submitted work.
: The protocol and all amendments were reviewed and approved by the West London & GTAC Research Ethics Committee of the Health Research Authority (National Health Service, UK: Reference 17/LO/1103) before the start of the study. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonisation guideline on Good Clinical Practice.
: All participants signed an informed consent form before any study-specific tests or procedures were performed.
: Not applicable.
: Availability of the data underlying this publication will be determined according to Bayer’s commitment to the European Federation of Pharmaceutical Industries and Associations and Pharmaceutical Research and Manufacturers of America principles for responsible clinical trial data sharing, pertaining to scope, time point, and process of data access. Bayer commits to sharing, upon request from qualified scientific and medical researchers, patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the USA and European Union as necessary for doing legitimate research. This commitment applies to data on new medicines and indications that have been approved by the European Union and US regulatory agencies on or after 1 January, 2014. Interested researchers can use ExternalRef removedto request access to anonymized patient-level data and supporting documents from clinical studies to perform further research that can help advance medical science or improve patient care. Information on the Bayer criteria for listing studies and other relevant information is provided in the study sponsors section of the portal. Data access will be granted to anonymized patient-level data, protocols, and clinical study reports after approval by an independent scientific review panel. Bayer is not involved in the decisions made by the independent review panel. Bayer will take all necessary measures to ensure that patient privacy is safeguarded. Requests for data listed as “unpublished data, Bayer AG, Berlin, Germany” should be made to Christian Friedrich, Director Experimental Medicine Clinician, Bayer AG Research & Development, Pharmaceuticals, Building M004, 525, 13353 Berlin, Germany. Email: christian.friedrich@bayer.com.
: Not applicable.
: CF, IG, SK, LF, CS, JAS, and AM participated in the conception, design, or planning of the study. CF, KF, and AM acquired and analyzed the data. JAS and AM were the coordinating investigators during the study. TH developed the taste strips used in the study. CF, AM, and JAS drafted the manuscript. All authors collaborated in the interpretation of study results and review of the manuscript, and approved the final draft for submission.