Li, Xuening
Haranaka, Miwa
Li, Hui
Liu, Pei http://orcid.org/0009-0003-2434-7164
Chen, Huijun
Klein, Stefan
Reif, Stefanie
Francke, Klaus
Friedrich, Christian
Okumura, Kazuhito
Clinical trials referenced in this document:
Documents that mention this clinical trial
P2X3 Receptor Antagonist Eliapixant in Phase I Clinical Trials: Safety and Inter-ethnic Comparison of Pharmacokinetics in Healthy Chinese and Japanese Participants
https://doi.org/10.1007/s40262-024-01387-y
Documents that mention this clinical trial
P2X3 Receptor Antagonist Eliapixant in Phase I Clinical Trials: Safety and Inter-ethnic Comparison of Pharmacokinetics in Healthy Chinese and Japanese Participants
https://doi.org/10.1007/s40262-024-01387-y
Funding for this research was provided by:
Bayer
Article History
Accepted: 22 May 2024
First Online: 21 June 2024
Declarations
:
: This study was funded by Bayer AG.
: P.L., H.C., S.K., S.R., K.F., and C.F. are employees of Bayer AG; K.O. works for Bayer Yakuhin Ltd.; and X.L., M.H., and H.L. have no conflicts of interest to declare.
: The data underpinning this publication are made available in line with Bayer’s commitment to the principles of responsible clinical trial data sharing adhered to by the European Federation of Pharmaceutical Industries and Associations and Pharmaceutical Research and the Manufacturers of America, in relation to the scope, time point, and process of data access. Bayer commits to sharing, upon request from qualified scientific and medical researchers, patient- and study-level clinical trial data and clinical trial patient protocols for medicines and indications approved in the USA and European Union as a necessary requirement for 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 January 1 2014. Interested researchers can use to request access to anonymized patient-level data and supporting documents from clinical studies to conduct further research that can help to advance medical science or improve patient care. Information on the Bayer criteria for listing studies and other relevant information is provided in the study sponsor 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 decisions made by the independent review panel. Bayer will take all necessary measures to ensure that patient privacy is safeguarded.
: These studies were conducted in accordance with the Good Clinical Practice guidelines and the Declaration of Helsinki. The protocols were reviewed and approved by each study site’s institutional review board.
: All participants provided written, informed consent.
: S.R., K.F., C.F., and K.O. contributed to the design of the Japanese study. M.H. was the principal investigator of the Japanese study. P.L., H.C., S.R., K.F., and C.F. contributed to the design of the Chinese study. X.L. was the principal investigator and H.L. the sub-investigator of the Chinese study. S.K. carried out the statistical analysis in the Japanese and Chinese studies, as well as the post hoc inter-ethnic analysis. All authors interpreted the data, critically reviewed and revised the manuscript, and approved the final version for publication.
: Not applicable.
: Not applicable.