NCT05711797

Pharmacokinetic Characteristics of Subjects with Hepatic Insufficiency and Healthy Subjects

An Open, Parallel Study Evaluating the Pharmacokinetic Profile, Safety, and Tolerability of a Single Oral Dose of ZX-7101A Tablets in Subjects with Mild or Moderate Liver Insufficiency and Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Nanjing Zenshine Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
DRUG	ZX-7101A 80mg	ZX-7101A a drug to treatment influenza in Chinese adults

Timeline

• Start date: 2023-04-12
• Primary completion: 2024-02-06
• Completion: 2024-08-09
• First posted: 2023-02-03
• Last updated: 2024-11-05

Locations

1 site across 1 country: China