NCT07282093

Pharmacokinetics of Olverembatinib in Participants With Hepatic Impairment

An Open-Label, Phase 1 Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of Olverembatinib

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a non-randomized, open-label, parallel, single-dose study to evaluate the pharmacokinetic profile of olverembatinib in participants with normal or impaired liver function.

Detailed description

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

Conditions

• Pharmacokinetic
• Olverembatinib

Interventions

Type	Name	Description
DRUG	Olverembatinib 20mg	orally after meal, single dose

Timeline

• Start date: 2025-11-11
• Primary completion: 2026-06-30
• Completion: 2026-10-31
• First posted: 2025-12-15
• Last updated: 2025-12-23

Locations

1 site across 1 country: China