期刊
LEUKEMIA & LYMPHOMA
卷 61, 期 6, 页码 1355-1363出版社
TAYLOR & FRANCIS LTD
DOI: 10.1080/10428194.2020.1719097
关键词
Zanubrutinib; hepatic impairment; pharmacokinetics; safety
资金
- BeiGene, Inc.
The pharmacokinetics and safety of single-dose zanubrutinib (80 mg) were assessed in subjects with mild, moderate, and severe hepatic impairment (n = 6 each, Child-Pugh class A, B, and C) relative to healthy controls (n = 11). Zanubrutinib median T-max was 1.25-2.25 h in all groups. Compared to control group, mean zanubrutinib exposure (AUC(0-inf)) in the mild and moderate hepatic impairment groups was increased by 1.1- and 1.2-fold, which is within the range of PK variability for zanubrutinib. The total and unbound AUC of zanubrutinib were 1.60- and 2.9-fold higher in subjects with severe hepatic impairment compared to healthy controls. Terminal half-life was comparable between subjects with hepatic impairment and matched healthy controls. Zanubrutinib was generally well-tolerated when administered as a single, 80-mg dose to subjects in this study. Results of this study will be used, in conjunction with clinical safety and efficacy data, to develop dose recommendations for patients with hepatic impairment.
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