NCT06671444

Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Severe Renal Impairment and Normal Renal Impairment

A Phase 1 Open-Label Single-Dose Study to Assess the Pharmacokinetics and Safety of YZJ-1139 in Subjects With Severe Renal Impairment and Renal Impairment

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Objective： 1. To evaluate the pharmacokinetics of YZJ-1139 tablets in patients with severe renal impairment and in subjects with normal renal impairment. 2. To evaluate the safety of YZJ-1139 tablets in patients with severe renal impairment and in subjects with normal renal impairment.

Conditions

• Insomnia
• Renal Impairment

Interventions

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

Timeline

• Start date: 2024-06-03
• Primary completion: 2024-11-10
• Completion: 2024-12-25
• First posted: 2024-11-04
• Last updated: 2024-11-04

Locations

3 sites across 1 country: China