Quizartinib for Heart Rate Effects
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is quizartinib generally safe for humans?
Quizartinib has been tested in humans and is generally considered tolerable, but it can cause QT prolongation (a heart rhythm issue) as a dose-limiting side effect. In clinical trials, some patients experienced mild to moderate side effects, and careful management is needed to avoid drug interactions that could increase the risk of heart-related issues.12345
How does the drug quizartinib differ from other treatments for heart rate effects?
Quizartinib is unique because it is primarily a tyrosine kinase inhibitor targeting the FLT3 receptor, used mainly for acute myeloid leukemia (AML). Its potential effects on heart rate are being studied, particularly its known side effect of QT prolongation, which is a measure of delayed heart repolarization that can lead to arrhythmias.12678
What is the purpose of this trial?
This study will evaluate the impact of rapid acceleration in the heart rate on the QT prolongation of quizartinib.
Research Team
Global Clinical Leader
Principal Investigator
Daiichi Sankyo
Eligibility Criteria
This trial is for healthy individuals who can safely undergo procedures to rapidly increase their heart rate. Specific eligibility details are not provided, but typically participants should have no significant medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of 90 mg of quizartinib or placebo on Day 1, and the alternate treatment on Day 2
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of treatment emergent adverse events
Treatment Details
Interventions
- Quizartinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Daiichi Sankyo
Lead Sponsor
Hiroyuki Okuzawa
Daiichi Sankyo
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
Yuki Abe
Daiichi Sankyo
Chief Medical Officer since 2023
MD