NCT06671509

Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Mild, Moderate and Normal Hepatic Impairment

A Phase 1 Open-Label Single-Dose Study to Assess the Pharmacokinetics and Safety of YZJ-1139 in Subjects With Mild, Moderate and Normal Hepatic Impairment

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

Summary

Primary Objectives: To evaluate the effect of the subjects with mild (Child Pugh A), moderate (Child Pugh B) and normal hepatic impairment on the pharmacokinetics of YZJ-1139 Secondary Objectives: To evaluate the safety of a single oral dose of YZJ-1139 in subjects with mild, moderate and normal hepatic impairment

Conditions

• Insomnia
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	YZJ-1139	Single oral dose, 20 mg tablet

Timeline

• Start date: 2024-03-22
• Primary completion: 2024-04-18
• Completion: 2024-08-07
• First posted: 2024-11-04
• Last updated: 2024-11-04

Locations

1 site across 1 country: China