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Clinical Trials in the USA / NCT06740799
Recruiting Phase 1

Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment

NCT06740799 · tracked via the Priya Life Science USA tracker
Sponsor
Daiichi Sankyo
Phase
Phase 1
Started
2024-09-30
Last updated
2026-04-01

Condition(s) studied

Hepatic Impairment

Investigational drug(s) / intervention(s)

Quizartinib

Quizartinib: Participants will receive a single oral dose of 30 mg

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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).

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Clinical Pharmacology of Miami, LLC Miami Florida Recruiting
Advanced Pharma Miami Florida Recruiting
GCP Research St. Petersburg Florida Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06740799 on ClinicalTrials.gov ↗ ← All trials in the USA