NCT05684653

Study to Evaluate Orelabrutinib Tablets in Subjects With Hepatic Impairment and Healthy Subject

An Open-Label, Parallel, Single-dose, Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of Orelabrutinib Tablets in Subjects With Varying Degrees of Hepatic Impairment

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

This is an Open-Label, Parallel, Single-dose, Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of Orelabrutinib Tablets in Subjects with Varying Degrees of Hepatic Impairment

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Orelabrutinib Tablets	50 mg, single oral dose

Timeline

• Start date: 2023-03-17
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2023-01-13
• Last updated: 2023-09-21

Locations

4 sites across 1 country: China