Reif, Stefanie http://orcid.org/0009-0005-3803-0728
Schultze-Mosgau, Marcus-Hillert
Engelen, Anna
Piel, Isabel
Denner, Karsten
Roffel, Ad
Tiessen, Renger
Klein, Stefan
Francke, Klaus
Rottmann, Antje
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
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
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: 29 October 2023
First Online: 3 December 2023
Declarations
:
: This study was funded by Bayer AG.
: Antje Rottmann, Isabel Piel, Karsten Denner, Marcus-Hillert Schultze-Mosgau, Klaus Francke, Stefanie Reif, and Stefan Klein are employees of Bayer AG. Anna Engelen was an employee of Bayer AG at the time the study was designed and conducted and is now an employee of Boehringer Ingelheim, Drug Discovery Sciences, Germany. Renger Tiessen and Ad Roffel are employees of ICON plc., Groningen, the Netherlands, formerly PRA Health Sciences, Groningen, the Netherlands. PRA Health Sciences were contracted by Bayer AG to perform the study.
: Both parts of the mass balance study were approved by the Medical Research Ethics Committee of the Beoordeling Ethiek Biomedisch Onderzoek (BEBO) Foundation, Assen, the Netherlands and conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki and the International Council for Harmonisation guidelines on Good Clinical Practice. The Central Committee on Research Involving Human Subjects [Centrale Commissie Mensgebonden Onderzoek (CCMO)] number was NL7431.056.20, and the EudraCT number was 2020-000519-54. The study was approved by the accredited ethics committee on 27 July 2020.
: All subjects in both study parts provided written informed consent.
: Not applicable.
: 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, timepoint, 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 performing 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 removed to 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. 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.
: Antje Rottmann, Isabel Piel, Anna Engelen, Karsten Denner, and Klaus Francke made substantial contributions to the conception or design of the work and the acquisition, analysis, and interpretation of the data. Marcus-Hillert Schultze-Mosgau and Stefanie Reif made significant contributions to the conception or design of the work, and analysis and interpretation of data. Stefan Klein made significant contributions to conception of the work and analysis of data. Ad Roffel and Renger Tiessen made significant contributions to the conception of the work and the acquisition and analysis of data. All authors drafted the manuscript or revised it critically for important intellectual content. All authors read and approved the final version of the manuscript and agreed that it should be published. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
: Medical writing services were provided by Richard Murphy, PhD of Adelphi Communications Ltd, Macclesfield, UK and funded by Bayer AG, Berlin, Germany in accordance with the Good Publication Practice guidelines, 2022.