NCT04796831

A Study to Determine the Absolute Oral Bioavailability of Quizartinib Using a Radiolabeled Microtracer in Healthy Subjects

An Open Label Study to Determine the Absolute Oral Bioavailability of Quizartinib Using a Radiolabeled Microtracer in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Quizartinib, a selective FLT3 inhibitor, is being developed as a treatment for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The absolute oral bioavailability of quizartinib has not yet been studied. This study is designed to estimate quizartinib bioavailability of quizartinib following oral and intravenous (IV) administration.

Detailed description

Quizartinib bioavailability based on the dose-adjusted exposure of quizartinib following oral and IV administration will be assessed in healthy male subjects. The primary objective of this study is to determine the absolute oral bioavailability of quizartinib. Secondary objectives will include characterizing the plasma PK of quizartinib, radiolabeled quizartinib, and the major circulating metabolite after a single oral dose and IV administration. Safety and tolerability of quizartinib will also be assessed.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Quizartinib dihydrochloride	Single oral dose of 60 mg quizartinib (2 x 30 mg tablets)
DRUG	14C-Quizartinib solution for infusion	50 μg solution for infusion containing NMT 22.84 kBq 14C in 5 mL; administered once as a 15-minute infusion

Timeline

• Start date: 2021-04-26
• Primary completion: 2021-06-11
• Completion: 2021-06-11
• First posted: 2021-03-15
• Last updated: 2023-01-11
• Results posted: 2023-01-11

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study