Effect of Food and Calcium on Pharmacokinetics of a Single Dose of S-888711 in Healthy Adult Volunteers

Exclusion Criteria

• •1. The use of prescription or non-prescription drugs, including herbal medicine or dietary supplements, within 14 days prior to dosing, with the exception of up to 3 doses of acetaminophen ≤ 1 gram each permitted from 14 days prior to the first study drug dose through 72 hours prior to the first study drug dose.
• •2. A history of regular use of tobacco- or nicotine-containing products within 6 months prior to Screening as confirmed by a urine cotinine test.
• •3. A history of use of inhibitors or inducers of cytochrome P450 (CYP) 3A4 within 14 days prior to Screening.
• •4. A history of use of platelet aggregation inhibitors, coronary artery vasodilators, calcium antagonists, beta blockers, diuretics, psychotropic drugs, prostaglandins, antibiotics, anticoagulants, and anticlotting or antiplatelet drugs (including aspirin and non-steroidal anti-inflammatory drugs) within 4 weeks prior to Screening.
• •5. History of use of thrombocytopenia-inducing drugs (eg, quinidine, trimethoprim sulfamethoxazole, etc.) within 4 weeks prior to Screening.
• •6. Family history of a hematologic disorder.
• •7. Hemorrhagic tendency.
• •8. A history of cardiac episode(s) or abnormal finding on electrocardiogram (ECG) and judged as ineligible by the investigator.
• •9. Chronic disease requiring medication and/or other treatment such as dietary restriction and physical therapy.
• •10. A history of anaphylaxis or significant side effect induced by a drug.
• •11. A history of allergic symptoms including food allergy, but excluding inactive pollen allergy.
• •12. A history of abuse of alcohol and/or drugs.
• •13. Positive urine screen for drug abuse.
• •14. A history of gastrointestinal surgery making subject ineligible as judged by the investigator.
• •15. Judged ineligible for this study by the investigator due to a history or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disease or other clinically important disorder.
• •16. Positive laboratory results for hepatitis A IgM antibody, hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus at Screening.
• •17. Donation of \>400 mL of blood within 12 weeks or \>200 mL of blood within 4 weeks prior to Screening.
• •18. Prior administration of S-888711.
• •19. Use of other investigational products within 30 days or 6 half-lives (whichever was longer) prior to the first dose of study medication.
• •20. Judged ineligible for this study by the investigator for any other reason.