Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment

Официальное название

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

Обзор

This study will evaluate and compare the PK in subjects with severe HI to that of matched healthy control subjects with normal hepatic function.

Подробное описание

This is a clinical pharmacology study with 2 cohorts (subjects with severe HI by Child-Pugh criteria and matched healthy control subjects) to evaluate the PK, safety, and tolerability of a single oral dose of 30 mg quizartinib in otherwise healthy subjects with severe HI (as defined by Child-Pugh criteria). This study is planned to be conducted at up to 3 sites in the US, which use Child-Pugh criteria.

Вмешательства

• Препарат Quizartinib
  Participants will receive a single oral dose of 30 mg

Первичные конечные точки

• Pharmacokinetic Parameter: Cmax [Срок оценки: From day of first dose, Day 1, through Day 29]
• Pharmacokinetic Parameter: Tmax [Срок оценки: From day of first dose, Day 1, through Day 29]
• Pharmacokinetic Parameter: AUClast [Срок оценки: From day of first dose, Day 1, through Day 29]
• Pharmacokinetic Parameter: AUCinf [Срок оценки: From day of first dose, Day 1, through Day 29]
• Pharmacokinetic Parameter: t1/2 [Срок оценки: From day of first dose, Day 1, through Day 29]

Вторичные конечные точки (1)

• Treatment Emergent Adverse Events [Срок оценки: From day of first dose, Day 1, up to 30 days after Day 29]

Критерии участия

Критерии включения

• Voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures.
• 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.
• 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:

• 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.
• In the opinion of the investigator, history of a clinically significant illness within 4 weeks prior to administration of quizartinib.
• Subjects with primary biliary cirrhosis or primary sclerosing cholangitis.
• Subjects with history of Gilbert's syndrome.
• Presence or history of clinically severe adverse reaction to any drug or known hypersensitivity to any of the ingredients (including inactive ingredients) of quizartinib.
• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Clinical Pharmacology of Miami, LLC — Miami
• Advanced Pharma — Miami
• GCP Research — St. Petersburg

Идентификаторы

NCT: NCT06740799 · AC220-163

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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