NCT04993404

Pharmacokinetics Of Jaktinib In Subjects With Hepatic Impairment And Normal Hepatic Function

Study To Evaluate The Pharmacokinetics Of Jaktinib Hydrochloride Tablets In Subjects With Hepatic Impairment And Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

This multi-center, open-label, parallel-controlled, single-dose Phase 1 study is being conducted to directly characterize the pharmacokinetic (PK) profiles and safety of Jaktinib following administration of a single oral dose in subjects with varying degrees of hepatic impairment compared to healthy matched control subjects with normal hepatic function(matched by age, weight, and sex).

Conditions

• Hepatic Insufficiency
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Jaktinib Hydrochloride Tablets	A single oral dose of 100 mg Jaktinib Hydrochloride Tablets will be administered.

Timeline

• Start date: 2021-08-27
• Primary completion: 2022-09-19
• Completion: 2022-09-19
• First posted: 2021-08-06
• Last updated: 2024-01-11

Locations

1 site across 1 country: China