Actively Recruiting
A Phase 1, Multicenter, Open-Label, Single-Dose Study to Assess the Pharmacokinetics, Safety and Tolerability of Quizartinib in Subjects With Severe Impaired Hepatic Function
Led by Daiichi Sankyo · Updated on 2026-04-01
12
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics (how the body absorbs, distributes, metabolizes, and eliminates a drug) of quizartinib in people with severe hepatic impairment compared to healthy individuals with normal liver function. This Phase 1 clinical pharmacology study aims to assess the safety and tolerability of quizartinib in these two groups using established liver function criteria called Child-Pugh. The study is sponsored by Daiichi Sankyo and conducted at up to three sites in the US. Participants will receive a single oral dose of 30 mg quizartinib. There are two groups: one with severe hepatic impairment and a matched healthy control group. Both groups will receive the same single dose to compare how the drug behaves in the body between those with liver impairment and healthy subjects. The study design is open-label and non-randomized. During the study, participants will be monitored from the first dose through 29 days to measure pharmacokinetic parameters such as maximum concentration (Cmax), time to maximum concentration (Tmax), area under the curve (AUClast and AUCinf), and half-life (t1/2). Safety will be assessed by recording any adverse events up to 30 days after the last measurement. The total participation duration includes the dosing day and follow-up visits for up to about one month.
CONDITIONS
Brief Title
Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily consents and provides written informed consent before any study procedures
- Male or female aged 18 to 75 years inclusive
- Body mass index (BMI) between 18 and 37 kg/m2 inclusive
- Minimum body weight of 40 kg at screening
- Females must have documented surgical sterilization, be postmenopausal for at least 1 year, have a sterile male partner, or agree to use contraception from screening until 7 months after quizartinib dose
- Females must agree not to retrieve eggs or ova via assisted reproductive technology during the study and for 7 months after last dose
- Males must have documented surgical sterilization, practice sexual abstinence, or agree to use contraception from screening until 4 months after quizartinib dose
- Males must agree to avoid sperm donation for 4 months after quizartinib dose
You will not qualify if you...
- Serious or unstable medical, psychiatric disorder, or other conditions interfering with safety or study compliance
- History of clinically significant illness within 4 weeks prior to quizartinib administration
- Diagnosis of primary biliary cirrhosis or primary sclerosing cholangitis
- History of Gilbert's syndrome
- History of severe adverse reaction or known hypersensitivity to quizartinib or its ingredients
- History of stomach or intestinal surgery affecting drug absorption or excretion, except appendectomy, hernia repair, or cholecystectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single oral dose of 30 mg quizartinib to evaluate pharmacokinetics, safety, and tolerability.
1 dosing visit and multiple follow-up visits up to Day 29
Duration - 30 days after Day 29
Participants are monitored for safety and adverse events for up to 30 days after the last pharmacokinetic assessment.
Multiple visits for safety monitoring
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
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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