NCT04473664

A Study of Quizartinib Pharmacokinetics in Participants With Moderate Hepatic Impairment

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The primary objective of this study is to determine the plasma pharmacokinetics (PK) of quizartinib and its pharmacologically active metabolite AC886 after a single oral dose of 30 mg in participants with moderate hepatic impairment (HI) (as defined by National Cancer Institute-Organ Dysfunction Working Group \[NCI-ODWG\] criteria) compared to the healthy control participants with normal hepatic function.

Conditions

• Hepatic Impairment
• Moderate Impaired Hepatic Function

Interventions

Type	Name	Description
DRUG	Quizartinib	Single oral dose, 30 mg tablet

Timeline

• Start date: 2020-09-22
• Primary completion: 2021-07-22
• Completion: 2021-07-22
• First posted: 2020-07-16
• Last updated: 2023-08-01
• Results posted: 2023-08-01

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study