Desch, Michael http://orcid.org/0000-0003-0205-1592
Wunderlich, Glen
Goettel, Markus
Goetz, Sophia
Liesenfeld, Karl-Heinz
Chan, Tom S.
Rosenbrock, Holger
Sennewald, Regina
Link, Jasmin
Keller, Sascha
Wind, Sven
Clinical trials referenced in this document:
Documents that mention this clinical trial
Effects of Cytochrome P450 3A4 Induction and Inhibition on the Pharmacokinetics of BI 425809, a Novel Glycine Transporter 1 Inhibitor
https://doi.org/10.1007/s13318-021-00723-y
Documents that mention this clinical trial
Effects of Cytochrome P450 3A4 Induction and Inhibition on the Pharmacokinetics of BI 425809, a Novel Glycine Transporter 1 Inhibitor
https://doi.org/10.1007/s13318-021-00723-y
Funding for this research was provided by:
Boehringer Ingelheim International GmbH
Article History
Accepted: 19 September 2021
First Online: 29 October 2021
Declarations
:
: The work presented here, including the conduct of the studies, data analysis, and interpretation, was funded by Boehringer Ingelheim International GmbH. The sponsor was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.
: MD, MG, SG, KHL, HR, RS, JL, SK, and SW are employees of Boehringer Ingelheim International GmbH, GW is an employee of Boehringer Ingelheim (Canada), and TSC is an employee of Boehringer Ingelheim Pharmaceuticals Inc. Authors did not receive any direct compensation relating to the development of this manuscript.
: The studies were conducted in compliance with the clinical study protocols and in accordance with the ethical principles of the Declaration of Helsinki [CitationRef removed], the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Harmonised Tripartite Guideline for Good Clinical Practice (GCP) [CitationRef removed], applicable regulatory requirements, and standard operating procedures of the sponsor company (Boehringer Ingelheim International GmbH). The study procedures, protocols, and documents were reviewed and approved by the Independent Ethics Committee of the study centre as well as the relevant local authorities.
: All participants provided a signed and dated informed consent form prior to any study-related procedure.
: Not applicable
: To ensure independent interpretation of clinical study results, Boehringer Ingelheim grants all external authors access to all relevant material, including participant-level clinical study data, and relevant material as needed by them to fulfill their role and obligations as authors under the ICMJE criteria.Furthermore, clinical study documents (e.g. study report, study protocol, statistical analysis plan) and participant clinical study data are available to be shared after publication of the primary manuscript in a peer-reviewed journal and if regulatory activities are complete and other criteria met per the BI Policy on Transparency and Publication of Clinical Study Data: ExternalRef removed.Prior to providing access, documents will be examined and, if necessary, redacted and the data will be de-identified to protect the personal data of study participants and personnel and to respect the boundaries of the informed consent of the study participants.Clinical Study Reports and Related Clinical Documents can also be requested via the link ExternalRef removed.All requests will be governed by a Document Sharing Agreement.Bona fide, qualified scientific and medical researchers may request access to de-identified, analysable participant clinical study data with corresponding documentation describing the structure and content of the datasets. Upon approval, and governed by a Data Sharing Agreement, data are shared in a secured data-access system for a limited period of 1 year, which may be extended upon request.Researchers should use the ExternalRef removed link to request access to study data.
: Not applicable.
: All authors contributed to the development of the manuscript, have revised it critically for important intellectual content, and have approved the version to be submitted. MD, KHL, and SW made substantial contributions to the conception or design of the work and the analysis or interpretation of data. GW, SG, TSC, and HR made substantial contributions to the conception or design of the work. MG and RS made substantial contributions to the conception or design of the work and the acquisition of data. JL and SK made substantial contributions to the analysis or interpretation of data.