Impact of target‐mediated drug disposition on hetrombopag pharmacokinetics and pharmacodynamics in Chinese healthy subjects and patients with chronic idiopathic thrombocytopenic purpura

• Published in: British journal of clinical pharmacology Vol. 88; no. 5; pp. 2084 - 2095
• Main Authors: Wang, Zhenlei, Zeng, Zhijun, Ye, Lijun, Zhu, Xiaohong, Pei, Yuwen, Wang, Yongsheng, Zheng, Li
• Format: Journal Article
• Language: English
• Published: England 01.05.2022
• Subjects: China; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; Healthy Volunteers; hetrombopag; Humans; Hydrazones; idiopathic thrombocytopenic purpura; Models, Biological; platelet countspopulation pharmacokinetic/pharmacodynamictarget‐mediated drug disposition; Purpura, Thrombocytopenic, Idiopathic - drug therapy; Pyrazolones - pharmacokinetics; China; platelet countspopulation pharmacokinetic/pharmacodynamictarget-mediated drug disposition; idiopathic thrombocytopenic purpura; hetrombopag

Aims The pharmacokinetics (PK) of hetrombopag were found to be nonlinear across evaluated dose ranges. The aim of this study was to develop a mechanism‐based population pharmacokinetic/pharmacodynamic (PopPK/PD) model and to provide a reasonable expected therapeutic dose for a future confirmatory cl...