Effects of Food on the Pharmacokinetics and Safety of HA121-28 Tablet, a Novel Multi-Targeting Tyrosine Kinase Inhibitor, in Healthy Chinese Subjects: A Phase I Clinical Trial

• Published in: Drug design, development and therapy Vol. 19; pp. 515 - 524
• Main Authors: Liu, Yixian, Li, Xiaoyu, Zhang, Mengyu, Men, Yuchun, Wang, Ying, Zhu, Xiaohong, Zheng, Li
• Format: Journal Article
• Language: English
• Published: New Zealand Taylor & Francis Ltd 01.01.2025; Dove; Dove Medical Press
• Subjects: Administration, Oral; Adult; Asian People; Calories; Cancer therapies; Clinical Trial Report; Clinical trials; Cross-Over Studies; Drinking water; Drug administration; Drug dosages; Drug resistance; East Asian People; Fasting; FDA approval; Female; Food; food effects; Food-Drug Interactions; Growth factors; ha121-28; Healthy Volunteers; Humans; Kinases; Lung cancer; Male; Mass spectrometry; Middle Aged; Mutation; Pharmacokinetics; Protein Kinase Inhibitors - administration & dosage; Protein Kinase Inhibitors - adverse effects; Protein Kinase Inhibitors - pharmacokinetics; Protein-Tyrosine Kinases - antagonists & inhibitors; Protein-Tyrosine Kinases - metabolism; Safety; Scientific imaging; Signal transduction; Tablets; Tyrosine; tyrosine kinase inhibitor; Tyrosine Kinase Inhibitors; Vascularization; Young Adult; China; pharmacokinetics; HA121-28; tyrosine kinase inhibitor; Food effects; safety

HA121-28, a novel multi-targeting tyrosine kinase inhibitor, has dual efficacy against tumor growth and neovascularization. The objectives of this study were to assess the effect of high-fat and high-calorie food on the pharmacokinetic (PK) profile and safety of HA121-28 tablet in healthy subjects....