Topletz-Erickson, Ariel R.
Mayor, JoAl G.
Liu, Hsu-Tai
Abdulrasool, Layth I.
Endres, Christopher J.
Clinical trials referenced in this document:
Documents that mention this clinical trial
Effect of Tucatinib on Cardiac Repolarization in Healthy Volunteers
https://doi.org/10.1007/s40268-023-00440-8
Funding for this research was provided by:
Seagen Inc.
Article History
Accepted: 24 August 2023
First Online: 26 September 2023
Declarations
:
: Funding for this publication was provided by Seagen Inc., Bothell, WA, USA.
: The authors wrote this article with the assistance of a medical writer funded by the sponsor. All authors had full access to the relevant data, vouch for the completeness and accuracy of the data and for adherence of the trial to the protocol, and assume final responsibility for the content of the article and the decision to submit the article for publication. Ariel R. Topletz-Erickson, JoAl G. Mayor, Hsu-Tai Liu, Layth I. Abdulrasool, and Christopher J. Endres are employees of Seagen and hold stocks and shares in Seagen.
: Qualified researchers may request access to certain data and related study documents consistent with the Principles for Responsible Clinical Trial Data Sharing. Interested researchers can use ExternalRef removed to request access to anonymized patient-level data and supporting documents from clinical studies to conduct further research that can help advance medical science or improve patient care.
: Before the start of this study, the study protocol and informed consent form were approved by a central Institutional Review Board (Midlands Independent Review Board, Overland Park, KS, USA). All amendments to the protocol were also approved by the Institutional Review Board. The study was designed and implemented in accordance with the International Council for Harmonisation of Technical Requirements for Human Use (ICH) E14 guidance on The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs [CitationRef removed]. The study was also conducted in accordance with the Declaration of Helsinki, Good Clinical Practice, and applicable regional and local legislation.
: All participants provided written consent prior to study enrolment.
: All authors contributed to the study design; analysis and interpretation of the data; and critical revisions of the article. All authors provided final approval for publication.
: All participants provided written consent prior to study enrolment.
: Not applicable.