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Completed Phase 1 Interventional Accepts healthy volunteers Results available

A Study of Quizartinib Pharmacokinetics in Participants With Moderate Hepatic Impairment

ClinicalTrials.gov ID: NCT04473664

Public ClinicalTrials.gov record NCT04473664. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 10:40 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-label, Single-dose Study to Assess the Pharmacokinetics, Safety and Tolerability of Quizartinib in Subjects With Moderate Impaired Hepatic Function as Defined by NCI-ODWG Criteria

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Quizartinib is a novel oral Class III receptor tyrosine kinase (RTK) inhibitor exhibiting highly potent and selective but reversible inhibition of Feline McDonough sarcoma (FMS)-like tyrosine kinase 3 (FLT3). Quizartinib is currently being studied alone or in combination with other agents as a treatment for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in adult and pediatric populations.

Study identification

NCT ID
NCT04473664
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Daiichi Sankyo
Industry
Enrollment
12 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 21, 2020
Primary completion
Jul 21, 2021
Completion
Jul 21, 2021
Last update posted
Jul 31, 2023

2020 – 2021

United States locations

U.S. sites
3
U.S. states
1
U.S. cities
2
Facility City State ZIP Site status
Clinical Pharmacology of Miami, LLC Miami Florida 33014-3616
Advanced Pharma Miami Florida 33147
Orlando Clinical Research Center Orlando Florida 32809

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04473664, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 31, 2023 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04473664 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →