drugset

drugset / Trial / NCT05185011

Study of the Pharmacokinetics and Safety of TPN171H Tablets in Subjects With Mild ,Moderate Hepatic Insufficiency and Normal Liver Function

NCT05185011 ↗

Phase 1 Completed 24 enrolled Vigonvita Life Sciences Shanghai Institute of Materia Medica, Chinese Academy of Sciences · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The study aims to investigate and compare the effect of TPN171H on subjects with mild and moderate hepatic impairment compared to healthy subjects.

Timeline

Start: 2021-12-16
Primary completion: 2022-02-06
Completion: 2022-02-06

Publications

Zhou J, Zhang H, Ding Y, Wang Z, Wang Y, Juan J, Jiang Z, Chen H. Pharmacokinetics and Safety of TPN171 (a PDE5 Inhibitor) in Patients With Mild or Moderate Hepatic Impairment Versus Participants With Normal Hepatic Function: A Phase 1 Study. Clin Pharmacol Drug Dev. 2025 Jun;14(6):472-478. doi: 10.1002/cpdd.1535. Epub 2025 Apr 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TPN171H	Unknown	10 mg	Oral

Indications