Actively Recruiting
Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment
Led by Daiichi Sankyo · Updated on 2026-04-01
12
Participants Needed
3
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any study procedures
- Male or female aged 18 to 75 years with BMI 18 to 37 kg/m2 and minimum weight of 40 kg
- Females must have documented surgical sterilization, be postmenopausal for at least 1 year, have a sterile male partner, or agree to use contraception until 7 months after quizartinib dose
- Females agree not to retrieve eggs via assisted reproductive technology during the study and for 7 months after last dose
- Males must have documented surgical sterilization, sexual abstinence, or agree to use contraception until 4 months after quizartinib dose
- Males agree to avoid sperm donation for 4 months after quizartinib dose
You will not qualify if you...
- Serious or unstable medical or psychiatric disorder that could affect safety or study compliance (except hepatic impairment)
- Clinically significant illness within 4 weeks before quizartinib administration
- Diagnosis of primary biliary cirrhosis or primary sclerosing cholangitis
- History of Gilbert's syndrome
- History of severe allergic reaction or hypersensitivity to quizartinib or its ingredients
- History of stomach or intestinal surgery that may affect drug absorption or excretion (except appendectomy, hernia repair, or cholecystectomy)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States, 33014
Actively Recruiting
2
Advanced Pharma
Miami, Florida, United States, 33147
Actively Recruiting
3
GCP Research
St. Petersburg, Florida, United States, 33705
Actively Recruiting
Research Team
D
Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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