A Phase I Study to Evaluate the Pharmacokinetics and Safety of TPN171 (a PDE5 Inhibitor) in Adults with Renal Impairment
文献类型：期刊论文
| 作者 | Fu, Ping3; Song, Yi2; Hu, Chao2,3; Yong, Xiaolan1; Yu, Yang3; Chen, Yi3; Wang, Ying2; Zhu, Xiaohong2; Wang, Zhen5 ; Wang, Yu5
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| 刊名 | CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT
 |
| 出版日期 | 2025-04-21 |
| 页码 | 8 |
| 关键词 | pharmacokinetics phosphodiesterase 5 inhibitor renal impairment safety TPN171 |
| ISSN号 | 2160-7648 |
| DOI | 10.1002/cpdd.1536 |
| 英文摘要 | TPN171, a phosphodiesterase 5 inhibitor, is under development for the treatment of male erectile dysfunction and pulmonary arterial hypertension in China. To investigate the pharmacokinetic properties and safety of TPN171 in individuals with severe renal impairment and normal renal function, an open-label, single-dose, parallel-group phase 1 study was conducted in 8 participants with severe renal impairment (glomerular filtration rate within 15-29 mL/min) and 8 participants having normal renal function, who received TNP171 tablets (10 mg) in the fasting state. As compared with those with normal renal function, the geometric mean ratios for maximum plasma concentration (Cmax), the 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 74.3%, 138%, and 137%, respectively. Elimination half-life was prolonged and clearance was decreased in severe renal impairment group. The adverse reaction rate showed no significant difference. All adverse events were mild intensity, and no participant was discontinued in this study. In conclusion, TPN171 can be cautiously used in patients with mild to severe renal impairment. |
| WOS关键词 | SELECTIVITY |
| 资助项目 | Vigonvita Life Sciences Co., Ltd. |
| WOS研究方向 | Pharmacology & Pharmacy |
| 语种 | 英语 |
| WOS记录号 | WOS:001470694800001 |
| 出版者 | WILEY |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/317476]  |
| 专题 | 新药研究国家重点实验室 |
| 通讯作者 | Miao, Jia |
| 作者单位 | 1.North Sichuan Med Coll, Chengdu Xinhua Hosp, Chengdu, Peoples R China 2.Sichuan Univ, West China Hosp, Clin Trial Ctr, Chengdu, Peoples R China 3.Sichuan Univ, West China Hosp, Dept Nephrol, Chengdu, Peoples R China 4.Vigonvita Life Sci Co Ltd, Suzhou, Peoples R China 5.Chinese Acad Sci, State Key Lab Drug Res, Shanghai Inst Mat Med, Shanghai, Peoples R China |
| 推荐引用方式 GB/T 7714 | Fu, Ping,Song, Yi,Hu, Chao,et al. A Phase I Study to Evaluate the Pharmacokinetics and Safety of TPN171 (a PDE5 Inhibitor) in Adults with Renal Impairment[J]. CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT,2025:8. |
| APA | Fu, Ping.,Song, Yi.,Hu, Chao.,Yong, Xiaolan.,Yu, Yang.,...&Miao, Jia.(2025).A Phase I Study to Evaluate the Pharmacokinetics and Safety of TPN171 (a PDE5 Inhibitor) in Adults with Renal Impairment.CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT,8. |
| MLA | Fu, Ping,et al."A Phase I Study to Evaluate the Pharmacokinetics and Safety of TPN171 (a PDE5 Inhibitor) in Adults with Renal Impairment".CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT (2025):8. |
入库方式： OAI收割
来源：上海药物研究所
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