Absorption, metabolism, excretion, and safety of [¹⁴C]almonertinib in healthy Chinese subjects.

ABSTRACT:

Background

Almonertinib Mesilate Tablets (HS-10296, Hansoh Pharma, Shanghai, China) is a novel and selective third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). A phase I study of almonertinib in patients with non-small cell lung cancer (NSCLC) demonstrated a linear metabolic trend, a good tolerability/safety profile, and preliminary antitumor activity. However, the metabolism, excretion, and substance balance of almonertinib has not been clearly determined. Here, we investigated the pharmacokinetic characteristics and safety profile of almonertinib following a single oral dose (110 mg/50 µCi) in healthy Chinese male participants.

Methods

Total radioactivity (TRA) in whole blood, plasma, urine, and feces was measured by utilizing a liquid

SUBMITTER: Zhou C 

PROVIDER: S-EPMC8184462 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature