A Study to Evaluate the Effects of E2609 on QTc Interval in Healthy Subjects

Exclusion Criteria

• •Subjects who meet any of the following criteria will be excluded from this study:
• •1. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before dosing
• •2. Evidence of disease that may influence the outcome of the study within 4 weeks before dosing (eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or subjects who have a congenital abnormality in metabolism)
• •3. Any history of gastrointestinal surgery that may affect PK profiles of study drugs (eg, hepatectomy, nephrectomy, or digestive organ resection)
• •4. Any clinically abnormal symptom or organ impairment found by medical history, physical examinations, vital signs, ECG finding, or laboratory test results that requires medical treatment at Screening or Baseline Periods
• •5. History of any medical condition which, in the opinion of the investigator, may interfere with study procedures or compromise subject safety
• •6. A prolonged QT/corrected QT interval (QTc) interval (QTc greater than 450 msec) as demonstrated by the mean of triplicate ECGs at Screening or Baseline Periods
• •7. History of risk factors for torsade de pointes or the use of concomitant medications that prolonged the QT/QTc interval
• •8. Persistent systolic blood pressure (BP) greater than 130 mmHg or less than 90 mmHg and diastolic BP greater than 85 mmHg or less than 60 mmHg at Screening or Baseline Periods
• •9. Heart rate less than 50 or greater than 100 beats/minute at Screening or Baseline Periods
• •10. History of prolonged QT/QTc interval
• •11. Left bundle branch block at Screening or Baseline Periods
• •12. History of myocardial infarction or active ischemic heart disease
• •13. History of clinically significant arrhythmia or uncontrolled arrhythmia
• •14. Any other clinically significant ECG abnormalities at Screening or Baseline Periods
• •15. Known history of clinically significant drug allergy (including to study drugs or any of their excipients) at Screening or Baseline
• •16. Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening or Baseline Periods
• •17. Active viral hepatitis (B or C) as demonstrated by positive serology at Screening
• •18. History of drug or alcohol dependency or abuse within the 2 years before Screening, or who have a positive urine drug or alcohol test at Screening or Baseline Periods
• •19. Use of recreational drugs
• •20. Intake of caffeinated beverages or food within 72 hours before dosing
• •21. Intake of nutritional supplements, juice, and herbal preparations or other foods or beverages that may affect the various drug metabolizing enzymes and transporters (eg, alcohol, grapefruit, grapefruit juice, grapefruit-containing beverages, apple or orange juice, vegetables from the mustard green family \[eg, kale, broccoli, watercress, collard greens, kohlrabi, brussel sprouts, mustard\], and charbroiled meats) within 1 week before dosing
• •22. Intake of herbal preparations containing St. John's Wort within 4 weeks before dosing
• •23. Use of prescription drugs within 4 weeks before dosing
• •24. Intake of over-the-counter (OTC) medications within 2 weeks before dosing
• •25. Smoking or use of tobacco or nicotine-containing products within 4 weeks before dosing
• •26. Engagement in strenuous exercise within 2 weeks before dosing (eg, marathon runners, weight lifters)
• •27. Currently enrolled in another clinical trial or used any investigational drug or device within 30 days preceding informed consent