Safety and Pharmacokinetics of Zanubrutinib (BGB-3111) in Healthy Subjects and Those With Impaired Liver Function

Phase 1 Completed 29 enrolled BeiGene

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in subjects with impaired liver function in comparison with healthy subjects

Timeline

Start: 2018-05-30
Primary completion: 2018-10-19
Completion: 2018-10-19

Publications

Results Ou YC, Preston RA, Marbury TC, Tang Z, Novotny W, Tawashi M, Li TK, Sahasranaman S. A phase 1, open-label, single-dose study of the pharmacokinetics of zanubrutinib in subjects with varying degrees of hepatic impairment. Leuk Lymphoma. 2020 Jun;61(6):1355-1363. doi: 10.1080/10428194.2020.1719097. Epub 2020 Feb 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zanubrutinib	Small molecule	80 mg	Oral

Indications

No indication recorded.