70 Participants Needed

Quizartinib for Heart Rate Effects

DS
Overseen ByDaiichi Sankyo Contact for Clinical Trial Information
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Daiichi Sankyo
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

GC

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

I am a male and have been surgically sterilized, practice abstinence, or agree to use contraception.
Vital signs at Screening within specified ranges: heart rate 50-100 bpm, systolic BP 90-145 mmHg, diastolic BP 50-95 mmHg
Liver function test results (ALT, AST, TBil) must be equal to or below the upper limit of normal
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Exclusion Criteria

I don't have any serious health or mental conditions that could affect my safety or the study's results.
I haven't had a serious illness in the last 4 weeks.
Pregnant or breastfeeding females
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of 90 mg of quizartinib or placebo on Day 1, and the alternate treatment on Day 2

3 days
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of treatment emergent adverse events

16 days

Treatment Details

Interventions

  • Quizartinib
Trial Overview The study is testing the effects of a drug called Quizartinib on the electrical activity of the heart when the heart rate is quickly increased. Some people will get Quizartinib and others a placebo (no active ingredient) to compare results.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Healthy ParticipantsExperimental Treatment2 Interventions
All participants will receive either an oral dose of 90 mg of quizartinib or placebo on Day 1. On Day 2, all participants will receive the treatment that was not given on Day 1.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Daiichi Sankyo

Lead Sponsor

Trials
443
Recruited
493,000+
Hiroyuki Okuzawa profile image

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe profile image

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Findings from Research

Quizartinib, a second-generation FLT3 inhibitor, effectively inhibits both mutant and wild-type FLT3 at low concentrations and has shown promising activity and tolerability in phase I and II trials for acute myeloid leukemia, with QT prolongation as a notable side effect.
The drug also inhibits the transport function of ABCG2 and ABCB1 proteins, which may enhance the effectiveness of certain chemotherapy drugs while also raising concerns about potential drug interactions, particularly with medications like ciprofloxacin that can affect heart rhythm.
The FLT3 inhibitor quizartinib inhibits ABCG2 at pharmacologically relevant concentrations, with implications for both chemosensitization and adverse drug interactions.Bhullar, J., Natarajan, K., Shukla, S., et al.[2021]
Quizartinib, a targeted therapy for acute myeloid leukaemia (AML), shows promise in treating patients with relapsed/refractory FLT3-ITD mutation-positive AML, but careful monitoring of genetic mutations is essential as patients may develop new mutations during treatment.
Patients may experience side effects such as QTc prolongation, which can be managed by dose adjustments, and careful selection of concomitant medications is crucial to avoid drug interactions, especially when preparing for procedures like hematopoietic stem cell transplant.
Practical Considerations for Treatment of Relapsed/Refractory FLT3-ITD Acute Myeloid Leukaemia with Quizartinib: Illustrative Case Reports.Martínez-Cuadrón, D., Rodríguez-Macías, G., Rodríguez-Veiga, R., et al.[2020]
In a study involving 64 healthy subjects, quizartinib showed similar absorption profiles whether taken after fasting or with a high-fat meal, indicating it can be administered without food restrictions.
Food intake delayed the time it took for quizartinib to reach its maximum concentration in the blood by 2 hours, but all reported adverse events were mild to moderate, with no serious safety concerns.
Effect of Food on the Pharmacokinetics of Quizartinib.Li, J., Holmes, M., Kankam, M., et al.[2021]

References

The FLT3 inhibitor quizartinib inhibits ABCG2 at pharmacologically relevant concentrations, with implications for both chemosensitization and adverse drug interactions. [2021]
Practical Considerations for Treatment of Relapsed/Refractory FLT3-ITD Acute Myeloid Leukaemia with Quizartinib: Illustrative Case Reports. [2020]
Effect of Food on the Pharmacokinetics of Quizartinib. [2021]
Effects of CYP3A inhibitors on the pharmacokinetics of quizartinib, a potent and selective FLT3 inhibitor, and its active metabolite. [2021]
Concentration-QTc analysis of quizartinib in patients with relapsed/refractory acute myeloid leukemia. [2021]
Effect of Futibatinib on Cardiac Repolarization: Results of a Randomized, Controlled, Double-Blind, QT/QTc, Phase 1 Study in Healthy Subjects. [2023]
Evaluation of the Potential for QTc Prolongation With Repeated Oral Doses of Fedratinib in Patients With Advanced Solid Tumors. [2022]
Quizartinib (AC220): a promising option for acute myeloid leukemia. [2020]
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