Lin, Swan http://orcid.org/0000-0002-7705-9401
Gong, Jason
Canas, George C.
Winkle, Peter
Pelletier, Kathleen
LaBadie, Robert R.
Ginman, Katherine
Pithavala, Yazdi K.
Clinical trials referenced in this document:
Documents that mention this clinical trial
A Phase I Study to Evaluate the Pharmacokinetics and Safety of Lorlatinib in Adults with Mild, Moderate, and Severe Renal Impairment
https://doi.org/10.1007/s13318-021-00747-4
Funding for this research was provided by:
Pfizer
Article History
Accepted: 12 December 2021
First Online: 11 January 2022
Change Date: 8 March 2022
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1007/s13318-022-00759-8
Declarations
:
: This study was sponsored by Pfizer Inc.
: All procedures in this study were in accordance with the 1964 Helsinki Declaration and its amendments, and the Aspire Institutional Review Board and Salus IRBs, which approved the study at the two clinical sites.
: All versions of the IRB-approved informed consent documents used in the study are included in the sponsor’s trial master file. All participants signed informed consent documents prior to participation in the trial; the signed informed consent documents are maintained at the respective investigator sites to preserve the confidentiality of the participants.
: Not applicable.
: The proprietary software program SAS was used for the analysis reported here.
: SL was an employee of Pfizer Inc. at the time of the study; JG is an employee of Pfizer Inc.; GCC and PW have no conflicts of interest; KP, RRL, KG, and YKP are employees of Pfizer Inc. and own stock in 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.
: SL, JG, KP, RRL, and YKP contributed toward writing the manuscript; SL, JG, GCC, PW, KP, RRL, KG, and YKP designed the research, and SL, JG, GCC, PW, KP, RRL, KG, and YKP analyzed and interpreted the data.