Evaluating quizartinib in patients with severe liver impairment

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

This study is testing how a single dose of quizartinib affects people with severe liver problems compared to healthy individuals to see if it's safe and how the body processes the medication.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Daiichi Sankyo (Industry-sponsored)
• Drugs / interventions: quizartinib
• Locations: 3 sites (Miami, Florida and 2 other locations)
• Trial ID: NCT06740799 on ClinicalTrials.gov

What this trial studies

This clinical pharmacology study aims to assess the pharmacokinetics (PK), safety, and tolerability of a single oral dose of 30 mg quizartinib in subjects with severe hepatic impairment, as defined by Child-Pugh criteria. The study will involve two cohorts: one consisting of subjects with severe hepatic impairment and another of matched healthy control subjects with normal liver function. The research will be conducted at up to three sites in the United States, focusing on comparing the PK profiles between the two groups.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with severe hepatic impairment as defined by Child-Pugh criteria.

Not a fit: Patients with mild to moderate hepatic impairment or those with normal liver function may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical insights into the safe use of quizartinib in patients with severe liver impairment.

How similar studies have performed: Other studies have explored pharmacokinetics in patients with hepatic impairment, but this specific evaluation of quizartinib is novel.

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).

Where this trial is running

Miami, Florida and 2 other locations

• Clinical Pharmacology of Miami, LLC — Miami, Florida, United States (Recruiting)
• Advanced Pharma — Miami, Florida, United States (Recruiting)
• GCP Research — St. Petersburg, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Daiichi Sankyo Contact for Clinical Trial Information

Conditions Hepatic Impairment; quizartinib