Evaluating the effects of quizartinib on heart rate in healthy individuals

A Single Blind, Fixed Sequence, Single-dose Study to Evaluate the Serious Risk of QTc Prolongation With Quizartinib in Healthy Subjects Under Rapid Acceleration of Heart Rate

This study is testing how a new heart medication called quizartinib affects heart rate and rhythm in healthy people.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Daiichi Sankyo (Industry-sponsored)
• Drugs / interventions: quizartinib
• Locations: 1 site (San Antonio, Texas)
• Trial ID: NCT06772246 on ClinicalTrials.gov

What this trial studies

This study assesses how rapid increases in heart rate affect QT prolongation when quizartinib is administered. A single oral dose of 90 mg of quizartinib will be given to 70 healthy subjects to monitor these effects. The study aims to gather data on the safety and heart rhythm changes associated with the drug under specific conditions. Participants will undergo vital sign assessments and laboratory tests to ensure they meet the eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates are healthy males and females aged 18 to 55 with specific BMI and vital sign criteria.

Not a fit: Patients with pre-existing heart conditions or those outside the specified age and health criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide important safety data for quizartinib, potentially leading to safer use in future treatments.

How similar studies have performed: While QT prolongation studies are common, the specific evaluation of quizartinib under rapid heart rate conditions is a novel approach.

Eligibility criteria

Key Inclusion Criteria:

1. Male and female subjects 18 to 55 years of age (inclusive), with a BMI of 18 kg/m2 to 32 kg/m2 (inclusive) with a minimum body weight of 40 kg at Screening.
2. Has vital signs (measured after subject has been supine for at least 5 minutes) at Screening within the following ranges: heart rate: 50-100 beats per minute (bpm); systolic blood pressure (BP): 90-145 mmHg; diastolic BP: 50-95 mmHg. Out-of-range vital signs may be repeated once.
3. Liver function test results (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and total bilirubin \[TBil\]) must be equal to or below the upper limit of normal.
4. Hemoglobin levels must ≥11.5 g/dL for female subjects and ≥12.5 g/dL for male subjects.
5. In females, documented surgical sterilization (ie, documented hysterectomy, bilateral tubal ligation, or bilateral salpingo-oophorectomy, Essure® with hysterosalpingogram \[documentation to confirm tubal occlusion 12 weeks after procedure\]), postmenopausal status for at least 1 year (follicle stimulating hormone \[FSH\] \> 40 mIU/mL serum and estradiol \<40 pg/mL \[\<147 pmol/L\] at Screening), or agreement to have a sterile male partner, or agreement to use 1 of the protocol-approved means of contraception from Screening until 7 months after the dose of quizartinib.
6. In males, documented surgical sterilization, or sexual abstinence, or agreement to use 1 of the protocol-approved means of contraception from Screening until 4 months after the single dose of quizartinib.

Key Exclusion Criteria:

1. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormality) that could interfere with subject's safety, obtaining informed consent, compliance to the study procedures, or the validity of the study results.
2. In the opinion of the investigator, history of a clinically significant illness within 4 weeks prior to administration of quizartinib.
3. History or presence of an abnormal ECG, which, in the investigator's opinion, is clinically significant and/or a QT interval corrected for heart rate using Fridericia's formula (QTcF) \>450 milliseconds (ms) at Screening
4. Females who are pregnant or breastfeeding
5. Laboratory results (serum chemistry, hematology, and urinalysis) outside the normal range, if considered clinically significant by the investigator. Estimated creatinine clearance (CrCl) \< 90 mL/min (calculated by Cockcroft-Gault equation) at Screening.

Where this trial is running

San Antonio, Texas

• Wct — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Daiichi Sankyo Contact for Clinical Trial Information

Conditions Healthy Subjects; quizartinib