Pharmacokinetics of Olverembatinib in Participants With Hepatic Impairment
NCT07282093 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2025-12-23
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.
Conditions
- Pharmacokinetic
- Olverembatinib
Interventions
- DRUG
-
Olverembatinib 20mg
orally after meal, single dose
Sponsors & Collaborators
-
Guangzhou Healthquest Pharma Co., Ltd
collaborator UNKNOWN -
Ascentage Pharma Group Inc.
lead INDUSTRY
Principal Investigators
-
Liyan Miao, M.D.,Ph.D. · M.D.,Ph.D.
-
Weifeng Zhao, M.D.,Ph.D. · The First Affiliated Hospital of Suzhou Medical University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-11-11
- Primary Completion
- 2026-06-30
- Completion
- 2026-10-31
Countries
- China
Study Locations
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