E7080 Food Effect Study in Healthy Subjects

Exclusion Criteria

• •1. Evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematological, neurological, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact the pharmacokinetics of study drug;
• •2. A clinically significant illness within 8 weeks or a clinically significant infection within 4 weeks, of dosing;
• •3. Evidence of organ dysfunction or any clinically significant deviation from normal in their medical history;
• •4. History of clinically significant drug or food allergies or presently experiencing seasonal allergies;
• •5. Evidence of clinically significant deviation from normal in physical examination, vital signs, electrocardiograms (ECG) or clinical laboratory determinations at Screening or Baseline;
• •6. Clinically significant ECG abnormality including a marked baseline prolongation of QT/QTc interval (eg repeated demonstration of a QTc interval greater than 500 msec), or a family history of prolonged QTc syndrome or sudden death;
• •7. History of drug or alcohol misuse within 6 months prior to Screening, or who have a positive urine drug test at Screening or Baseline;
• •8. Positive result for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV) screen, or a positive syphilis screen;
• •9. Diagnosed with acquired immune deficiency syndrome (AIDS), or test positive for human immunodeficiency virus (HIV);
• •10. Participated in another clinical trial less than 4 weeks prior to dosing or who are currently enrolled in another clinical trial;
• •11. Consumed caffeinated beverages or food within 72 hours prior to dosing;
• •12. Consumed grapefruit or grapefruit containing beverages or food within 72 hours prior to dosing;
• •13. Experienced a weight loss or gain of greater than 10% within 4 weeks of dosing;
• •14. Engaged in heavy exercise (greater than or equal to 1 hour/day 5 times/week) less than 2 weeks prior to Baseline (eg, marathon runners, weight lifters, etc.);
• •15. Received blood products within 4 weeks, or donated blood within 8 weeks, or donated plasma within 1 week, of dosing;
• •16. Hemoglobin level less than 12.0 g/dL;
• •17. Used prescription drugs within 2 weeks prior to screening;
• •18. Taken over-the-counter (OTC) medications within 2 weeks prior to dosing;
• •19. Any condition that would make him/her in the opinion of the Investigator or Sponsor, unsuitable for the study or who, in the opinion of the Investigator, is not likely to complete the study for any reason;
• •20. Inability to tolerate venepuncture and/or venous access;
• •21. History of depression, deliberate self harm or suicidal ideation.