drugset / Trial / NCT05711797
Pharmacokinetic Characteristics of Subjects with Hepatic Insufficiency and Healthy Subjects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ZX-7101A | Unknown | 80 mg | Oral |