Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment

NCT06740799 | Recruiting Phase 1 FDA Drug

• 1 other identifier: AC220-163
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hepatic Impairment

Keywords

quizartinib

Outcome Measures

Primary Outcomes (5)

• Pharmacokinetic Parameter: Cmax

  Maximum concentration, determined directly from individual concentration-time data

  From day of first dose, Day 1, through Day 29

• Pharmacokinetic Parameter: Tmax

  Time of the maximum concentration

  From day of first dose, Day 1, through Day 29

• Pharmacokinetic Parameter: AUClast

  Area under the concentration-time curve from time-zero to the time of the last quantifiable concentration; calculated using the linear up log down

  From day of first dose, Day 1, through Day 29

• Pharmacokinetic Parameter: AUCinf

  Area under the concentration-time curve from time-zero extrapolated to infinity

  From day of first dose, Day 1, through Day 29

• Pharmacokinetic Parameter: t1/2

  The observed terminal half-life

  From day of first dose, Day 1, through Day 29

Secondary Outcomes (1)

• Treatment Emergent Adverse Events

  From day of first dose, Day 1, up to 30 days after Day 29

Study Arms (2)

Severe HI

EXPERIMENTAL

Participants will receive a single oral dose of 30 mg quizartinib

Drug: Quizartinib

Control Group

EXPERIMENTAL

Healthy participants will receive a single oral dose of 30 mg quizartinib

Drug: Quizartinib

Interventions

Quizartinib DRUG

Participants will receive a single oral dose of 30 mg

Also known as: Test Product, VANFLYTA®

Control Group; Severe HI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (3)

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014, United States

RECRUITING

Advanced Pharma

Miami, Florida, 33147, United States

RECRUITING

GCP Research

St. Petersburg, Florida, 33705, United States

RECRUITING

MeSH Terms

Interventions

quizartinib

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Central Study Contacts

Daiichi Sankyo Contact for Clinical Trial Information

CONTACT

908-992-6400; CTRinfo_us@daiichisankyo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking,
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

US (3)