A Study to Evaluate QTc Prolongation With Quizartinib in Healthy Subjects Under Rapid Acceleration of Heart Rate

Key Inclusion Criteria:

1. Male and female subjects 18 to 55 years of age (inclusive), with a BMI of 18 kg/m2to 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) atScreening 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-rangevital signs may be repeated once.

3. Liver function test results (alanine aminotransferase [ALT], aspartateaminotransferase [AST], and total bilirubin [TBil]) must be equal to or below theupper limit of normal.

4. Hemoglobin levels must ≥11.5 g/dL for female subjects and ≥12.5 g/dL for malesubjects.

5. In females, documented surgical sterilization (ie, documented hysterectomy,bilateral tubal ligation, or bilateral salpingo-oophorectomy, Essure® withhysterosalpingogram [documentation to confirm tubal occlusion 12 weeks afterprocedure]), 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), oragreement to have a sterile male partner, or agreement to use 1 of theprotocol-approved means of contraception from Screening until 7 months after thedose of quizartinib.

6. In males, documented surgical sterilization, or sexual abstinence, or agreement touse 1 of the protocol-approved means of contraception from Screening until 4 monthsafter the single dose of quizartinib.

Key Exclusion Criteria:

1. Any serious and/or unstable pre-existing medical, psychiatric disorder, or otherconditions (including lab abnormality) that could interfere with subject's safety,obtaining informed consent, compliance to the study procedures, or the validity ofthe study results.

2. In the opinion of the investigator, history of a clinically significant illnesswithin 4 weeks prior to administration of quizartinib.

3. History or presence of an abnormal ECG, which, in the investigator's opinion, isclinically significant and/or a QT interval corrected for heart rate usingFridericia'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 normalrange, if considered clinically significant by the investigator. Estimatedcreatinine clearance (CrCl) < 90 mL/min (calculated by Cockcroft-Gault equation) atScreening.