NCT06093230

A Study in Subjects With Liver Function Injury and Subjects With Normal Liver Function

An Open-label, Single-dose, Phase I Study to Assess the Pharmacokinetics and Safety of JT001 in Subjects With Mild and Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Shanghai Vinnerna Biosciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Evaluate the pharmacokinetic differences of the main metabolite 116-N1 of JT001 in subjects with mild and moderate liver function impairment and those with normal liver function, providing a basis for formulating clinical medication plans for patients with liver function impairment;

Detailed description

This study adopts a non randomized, open, parallel controlled, single dose experimental design and is divided into three experimental groups: mild liver function impairment group (Group A), moderate liver function impairment group (Group B), and normal liver function subject group (Group C). Subjects in each experimental group took 0.3g of JT001 orally on an empty stomach and collected blood samples before and after administration for pharmacokinetic analysis. After both groups A and B were enrolled, Group C subjects will be enrolled subsequently and should be matched with subjects with liver function impairment (Group A and Group B) as following: The average body weight of Group C is within ± 10 kg of the average body weight of the group of subjects with liver function impairment (Groups A and B). The average age of Group C is within ± 10 years of the average age of the group of subjects with liver function impairment (Groups A and B). The number of subjects of each gender in Group C is similar to that in the liver function impairment group (A and B groups) (± 1 subject/gender). The study is divided into three stages: screening period, baseline period, and experimental period.

Conditions

• Subjects With Liver Function Injury
• Normal Liver Function Subject

Interventions

Type	Name	Description
DRUG	Deuremidevir Hydrobromide Tablets	JT001 single dose, 0.3g

Timeline

• Start date: 2023-07-28
• Primary completion: 2023-08-18
• Completion: 2023-08-18
• First posted: 2023-10-23
• Last updated: 2023-10-23

Locations

1 site across 1 country: China