NCT06888115

A Study of the Pharmacokinetics and Safety of CS0159 in Subjects With Hepatic Injury

Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of CS0159 Tablets in Subjects With Mild (Child-Pugh: Class A), Moderate (Child-Pugh: Class B) Hepatic Impairment, and Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Cascade Pharmaceuticals, Inc · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Phase I Study of the Pharmacokinetics and Safety of CS0159 in Subjects With Hepatic Injury

Detailed description

To evaluate the PK characteristics of CS0159 in subjects with mild hepatic impairment (Child-Pugh Class A), moderate hepatic impairment (Child-Pugh Class B), and sex, age, and body weight-matched healthy subjects with normal hepatic function, so as to provide a scientific basis for the appropriate dose and/or dosing interval adjustment in subjects with hepatic impairment.

Conditions

• Primary Biliary Cholangitis

Interventions

Type	Name	Description
DRUG	CS0159	Single oral dose of CS0159 4mg

Timeline

• Start date: 2025-03-13
• Primary completion: 2025-05-29
• Completion: 2025-06-03
• First posted: 2025-03-21
• Last updated: 2025-07-11

Locations

3 sites across 1 country: China

Regulatory

• FDA-regulated drug study