CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 8 enrolled
Drug / intervention
Quizartinib dihydrochloride +1 moredrug
Likely dose
Quizartinib dihydrochloride 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04796831
NCT04796831Phase 1Completed
CompareCT.gov

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

Daiichi Sankyo·interventional·Posted Mar 15, 2021·Updated Jan 11, 2023

In Brief

A Phase 1 clinical trial evaluating Quizartinib dihydrochloride and 14C-Quizartinib solution for infusion for Healthy Subjects. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects
CountriesUnited Kingdom
CollaboratorsQuotient Sciences

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedMar 15, 2021
Enrollment StartApr 26, 2021
Primary CompletionJun 11, 2021
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 5.3 years ago

Interventions

Quizartinib dihydrochloridedrug

Single oral dose of 60 mg quizartinib (2 x 30 mg tablets)

14C-Quizartinib solution for infusiondrug

50 μg solution for infusion containing NMT 22.84 kBq 14C in 5 mL; administered once as a 15-minute infusion