Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment

Launched by DAIICHI SANKYO · Dec 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called quizartinib to understand how it is processed by the body in people with severe liver problems compared to healthy individuals with normal liver function. The research aims to gather important information about how the drug behaves in those with liver impairment, which can help in ensuring safe and effective treatment for this group.

To participate in the study, individuals should be between 18 and 75 years old and have a body mass index (BMI) within a specific range. They must also be able to provide informed consent and meet certain health criteria. Participants can expect to undergo tests and evaluations to monitor their health throughout the trial. It's important to note that individuals with specific serious health issues or certain liver-related conditions may not be eligible to join the study. Overall, this trial aims to contribute valuable knowledge for treating patients with liver impairments safely.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures.
• • 2. Male and female subjects 18 to 75 years of age (inclusive), with a body mass index (BMI) of 18 kg/m2 to 37 kg/m2 (inclusive) with a minimum body weight of 40 kg at Screening.
• • 3. In females, documented surgical sterilization (ie, documented hysterectomy, bilateral tubal ligation, or bilateral salpingo-oophorectomy, Essure® with hysterosalpingogram \[documentation to confirm tubal occlusion 12 weeks after procedure\]), postmenopausal status for at least 1 year (follicle stimulating hormone \[FSH\] \> 40 mIU/mL serum and estradiol \<40 pg/mL \[\<147 pmol/L\] at Screening), or agreement to have a sterile male partner, or agreement to use 1 of the means of contraception from Screening until 7 months after the dose of quizartinib 4. In females, agreement to not retrieve eggs/ova via assisted reproductive technology (ART) either for their own use or donation while on the study or for 7 months after the last dose of study drug, whichever is later.
• • 5. In males, documented surgical sterilization, sexual abstinence, or agreement to use 1 of the means of contraception from Screening until 4 months after the dose of quizartinib 6. In males, agreement to avoid sperm donation for 4 months after the dose of quizartinib
• Key Exclusion:
• • 1. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormality except hepatic impairment) that could interfere with safety, obtaining informed consent, compliance to the study procedures, or the validity of the study results.
• • 2. In the opinion of the investigator, history of a clinically significant illness within 4 weeks prior to administration of quizartinib.
• • 3. Subjects with primary biliary cirrhosis or primary sclerosing cholangitis.
• • 4. Subjects with history of Gilbert's syndrome.
• • 5. Presence or history of clinically severe adverse reaction to any drug or known hypersensitivity to any of the ingredients (including inactive ingredients) of quizartinib.
• • 6. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (with the exception of appendectomy, hernia repair, and/or cholecystectomy).