Piscitelli, Joseph
Chen, Joseph
LaBadie, Robert R.
Salageanu, Joanne
Chung, Chin-Hee
Tan, Weiwei
Clinical trials referenced in this document:
Documents that mention this clinical trial
The Effect of Hepatic Impairment on the Pharmacokinetics of Dacomitinib
https://doi.org/10.1007/s40261-022-01125-x
Documents that mention this clinical trial
The Effect of Hepatic Impairment on the Pharmacokinetics of Dacomitinib
https://doi.org/10.1007/s40261-022-01125-x
Funding for this research was provided by:
Pfizer
Article History
Accepted: 3 February 2022
First Online: 23 February 2022
Declarations
:
: This study was sponsored by Pfizer Inc.
: This research was sponsored by Pfizer Inc. Joseph Chen, Robert R. LaBadie, Joanne Salageanu, Chin-Hee Chung, and Weiwei Tan are employees of Pfizer Inc. and may own Pfizer stock. Joseph Piscitelli (Postdoctoral Fellow) was an unpaid contractor to Pfizer; the fellowship program with the University of California San Diego was supported by an educational grant from Pfizer.
: Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions and exceptions, Pfizer may also provide access to the related individual de-identified participant data. See ExternalRef removed for more information.
: Not applicable.
: JP: acquisition and interpretation of data. JC: study design, acquisition and interpretation of data. RRL: study design, interpretation of data. JS: interpretation of data. CC: study design, acquisition and interpretation of data. WT: study design, acquisition and interpretation of data. All authors reviewed and provided intellectual contributions on previous versions of the manuscript and read and approved the final manuscript.
: These studies were conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. In addition, all local regulatory requirements were followed, in particular those affording greater protection to the safety of trial participants. An Institutional Review Board approved the protocols and all participants gave written, informed consent. These trials were registered on ClinicalTrials.gov: NCT01571388 (Study 1); NCT03865446 (Study 2).
: All participants provided written informed consent before undergoing any study procedures.
: Not applicable.