Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment
NCT06740799 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-04-01
Summary
This study will evaluate and compare the PK in subjects with severe HI to that of matched healthy control subjects with normal hepatic function.
Conditions
- Hepatic Impairment
Interventions
- DRUG
-
Quizartinib
Participants will receive a single oral dose of 30 mg
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Global Clinical Leader · Daiichi Sankyo
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
- 2024-09-30
- Primary Completion
- 2026-10-31
- Completion
- 2026-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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