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

NCT04796831 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-01-11

Study results available
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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.

Conditions

  • Healthy Subjects

Interventions

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

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • Daiichi Sankyo

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-26
Primary Completion
2021-06-11
Completion
2021-06-11
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04796831 on ClinicalTrials.gov