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Pharmacokinetics and Safety of TPN171 (a PDE5 Inhibitor) in Patients With Mild or Moderate Hepatic Impairment Versus Participants With Normal Hepatic Function: A Phase I Study

文献类型：期刊论文

作者Zhou, Jing2; Zhang, Hong2; Ding, Yanhua2; Wang, Zhen1; Wang, Yu1; Juan, Jiaxiang3; Jiang, Zhicheng3; Chen, Hong2
刊名CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT
出版日期2025-04-25
页码7
关键词hepatic impairment pharmacokinetics phosphodiesterase-5 inhibitor TPN171
ISSN号2160-7648
DOI10.1002/cpdd.1535
英文摘要TPN171 is a phosphodiesterase-5 inhibitor. It is currently being developed in China to treat pulmonary arterial hypertension and erectile dysfunction (ED). This study aimed to compare the pharmacokinetics and safety of TPN171 across participants with normal hepatic function and hepatic impairment (HI). An open-label, single-dose, parallel-group study enrolled participants with normal hepatic function (group C) and mild-to-moderate HI (groups A and B). In each cohort, 8 participants completed the study. Blood samples were collected up to 72 hours after 10 mg oral TPN171 administration. The maximum plasma concentration (Cmax), area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC0-t), and AUC extrapolated to infinite time (AUC0-infinity) were compared between the groups. Cmax, AUC0-t, and AUC0-infinity were higher in groups A and B than in group C (geometric mean ratios 1.17-1.20, 1.46-1.53, and 1.45-1.54, respectively), while the elimination half-time was prolonged and clearance was reduced in the HI groups. All adverse events were not serious and no participant withdrew from this study. Considering the increase in TPN171 plasma exposure, the highest dose of 5 mg TPN171 is recommended in patients with ED having mild-to-moderate HI.
WOS关键词ERECTILE ; SILDENAFIL ; AVANAFIL ; AGE
资助项目Vigonvita Life Sciences Co., Ltd ; Vigonvita Life Sciences Co., Ltd.
WOS研究方向Pharmacology & Pharmacy
语种英语
WOS记录号WOS:001474929400001
出版者WILEY
源URL[http://119.78.100.183/handle/2S10ELR8/317545]  
专题新药研究国家重点实验室
通讯作者Chen, Hong
作者单位1.Chinese Acad Sci, Shanghai Inst Mat Med, State Key Lab Drug Res, Shanghai, Peoples R China
2.First Hosp Jilin Univ, Pharse 1 Clin Res Ctr, Changchun 130021, Jilin, Peoples R China
3.Vigonvita Life Sci Co Ltd, Clin Dev Dept, Suzhou, Peoples R China
推荐引用方式
GB/T 7714		 Zhou, Jing,Zhang, Hong,Ding, Yanhua,et al. Pharmacokinetics and Safety of TPN171 (a PDE5 Inhibitor) in Patients With Mild or Moderate Hepatic Impairment Versus Participants With Normal Hepatic Function: A Phase I Study[J]. CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT,2025:7.
APA Zhou, Jing.,Zhang, Hong.,Ding, Yanhua.,Wang, Zhen.,Wang, Yu.,...&Chen, Hong.(2025).Pharmacokinetics and Safety of TPN171 (a PDE5 Inhibitor) in Patients With Mild or Moderate Hepatic Impairment Versus Participants With Normal Hepatic Function: A Phase I Study.CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT,7.
MLA Zhou, Jing,et al."Pharmacokinetics and Safety of TPN171 (a PDE5 Inhibitor) in Patients With Mild or Moderate Hepatic Impairment Versus Participants With Normal Hepatic Function: A Phase I Study".CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT (2025):7.

入库方式： OAI收割

来源：上海药物研究所

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