Perera, Vidya http://orcid.org/0000-0002-9055-0123
Abelian, Grigor
Li, Danshi
Wang, Zhaoqing
Zhang, Liping
Lubin, Susan
Chen, Wei
Bello, Akintunde
Murthy, Bindu
Clinical trials referenced in this document:
Documents that mention this clinical trial
Single-Dose Pharmacokinetics of Milvexian in Participants with Mild or Moderate Hepatic Impairment Compared with Healthy Participants
https://doi.org/10.1007/s40262-022-01110-9
Funding for this research was provided by:
This study was sponsored by Bristol Myers Squibb and Janssen Research & Development, LLC
Article History
Accepted: 1 February 2022
First Online: 9 March 2022
Declarations
:
: This study was sponsored by Bristol Myers Squibb and Janssen Research & Development, LLC.
: VP, GA, DL, ZW, SL, WC, AB, and BM are full-time employees of Bristol Myers Squibb. LZ is a full-time employee of Janssen Research & Development, LLC.
: The data that support the findings of this study are not publicly available due to privacy or ethical restrictions.
: Not applicable.
: VP, GA, DL, ZW, LZ, SL, WC, AB, and BM contributed to the study design and concept, data analysis and review, data interpretation, and manuscript review.
: This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and underlying EU Directive 2001/20/EC and the US Code of Federal Regulations, Title 21, Part 50 (21CFR50). Good clinical practice was followed, as defined by the International Council for Harmonisation. The study was registered with ClinicalTrials.gov (NCT02982707). The study protocol and all amendments were reviewed and approved by the Chesapeake Institutional Review Board, Columbia, MD, USA, according to specifications outlined in applicable regulations.
: Prior to beginning the study, all participants provided written informed consent, including consent for any screening procedures conducted to establish participant eligibility for the study.
: Not applicable.