drugset / Trial / NCT05711797

Pharmacokinetic Characteristics of Subjects with Hepatic Insufficiency and Healthy Subjects

NCT05711797

Phase 1 Completed 16 enrolled Nanjing Zenshine Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The objective of this multicenter, open, single-dose, parallel controlled, Phase I clinical study is to Evaluate a single oral ZX-7101A PK in subjects with varying degrees of (mild or moderate) liver insufficiency compared with healthy subjects matched by age, weight, and sex. And to evaluate the the safety and tolerability of ZX-7101A by a single oral dose in subjects. The main questions it aims to answer are: * Evaluate a single oral ZX-7101A PK in subjects with varying degrees of (mild or moderate) liver dysfunction and healthy subjects with normal liver function matched for age, weight, and sex. * To evaluate the safety and tolerability of ZX-7101A by a single oral dose in subjects.

Timeline

Start
2023-04-12
Primary completion
2024-02-06
Completion
2024-08-09

Drugs

EvaluationDrugModalityDoseRoute
Subject ZX-7101A Unknown 80 mg Oral

Indications