NCT04145596

Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Patients With Hepatic Impairment

A Phase 1 Study to Investigate a Single Bolus Dose Followed With a 30 Minute Constant Infusion of HSK3486 on the Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Patients With Hepatic Impairment (Single-Center, Open-label, Parallel-Group)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

Comparison of the pharmacokinetics/Pharmacodynamics of the HSK3486 in Patients With Mild and Moderate Hepatic Impairment Compared with Healthy Volunteers

Detailed description

This is a single-center, open-label, non-randomized, parallel-controlled Phase I clinical study carried out in patients with compensated chronic liver disease (Child-Pugh A), patients with decompensated chronic liver disease (Child-Pugh B), and age-, weight-, and gender-matched subjects with normal liver functions.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	HSK3486	HSK3486，Initially 0.4 mg/kg was administered as a 1 minute bolus, followed immediately by a constant infusion dose of 0.4 mg/kg/h administered as a 30 minute infusion via infusion pump.

Timeline

• Start date: 2019-11-14
• Primary completion: 2020-04-20
• Completion: 2020-07-13
• First posted: 2019-10-30
• Last updated: 2020-12-17

Locations

1 site across 1 country: China