NCT06620731

Clinical Trial of FCN-437c Capsule in Patients With Hepatic Insufficiency

Single-dose, Parallel, Open-label Pharmacokinetic Study of FCN-437c Capsule in Subjects With Impaired Liver Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Ahon Pharmaceutical Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

To evaluate and compare the safety and efficacy of FCN-437c in subjects with mild and moderate liver impairment and healthy subjects, and to provide a basis for clinical medication in patients with liver impairment.

Conditions

• Hepatic Insufficiency

Interventions

Type	Name	Description
DRUG	FCN-437c capsule	Take 200 mg of FCN-437c capsules with approximately 240 mL of warm water in the morning on an empty stomach.

Timeline

• Start date: 2023-09-04
• Primary completion: 2023-09-27
• Completion: 2023-09-27
• First posted: 2024-10-01
• Last updated: 2024-11-12

Locations

1 site across 1 country: China