Effects of a Double-Blind, Single Dose of PER977 Administered Alone, and Following a Single Dose of Edoxaban

Exclusion Criteria

• •1. History or current evidence of clinically significant cardiac, hepatic, renal, pulmonary, endocrine, neurologic, infectious, gastrointestinal, hematologic, or oncologic disease as determined by screening history, physical examination, laboratory test results or 12-lead ECG. History or current evidence of liver function tests greater than the upper limit of normal. History or current evidence of QTc Fridericia (QTcF) greater than normal (430±10 msec for males or 450±10 msec for females; average of three measurements).
• •2. History of unexplained syncope
• •3. Use of any drugs or substances known to be strong inhibitors or strong inducers of CYP3A4/5 transporters of p-glycoprotein within 28 days prior to the first dosing
• •4. History of major bleeding, trauma, surgical procedure of any type, or vaginal delivery within six months prior to screening
• •5. History of peptic ulcer, gastrointestinal bleeding (including hematemesis, melena, rectal bleeding) or bleeding from hemorrhoids within six months prior to screening
• •6. History of minor bleeding episodes such as epistaxis, rectal or hemorrhoidal bleeding (spots of blood on toilet paper) or gingival bleeding within 3 months prior to screening
• •7. Personal or family history of clotting disorder or abnormality, excessive bleeding, thrombovascular disease or any hematologic disorder involving platelets or clotting abnormalities or any condition requiring treatment with transfusions, anticoagulants or platelet inhibitors
• •8. Females with a history of dysfunctional uterine bleeding, including history of menorrhagia (heavy menstrual bleeding), metrorrhagia or polymenorrhea or current use of hormonal contraceptives.
• •9. Pregnant or breast-feeding
• •10. Male subjects with a history of hormone therapy within the 3 months prior to screening
• •11. Administration of any blood product or anticoagulant within 3 months prior to study entry or any non-steroidal anti-inflammatory drug or cyclooxygenase inhibitor within 2 weeks prior to screening
• •12. Taking any type of chronic medication within the 4 weeks prior to study entry
• •13. Positive serologic test for human immunodeficiency virus (HIV), Hepatitis C virus (HCV), or Hepatitis B surface antigen (HBsa)
• •14. Use of any of the following medications in the 4 weeks prior to study entry: rifampin, dronedarone, ketoconazole, verapamil, amiodarone, quinidine, clopidogrel, oral anticoagulants, or other agent known to interact with edoxaban
• •15. Donation of blood or blood products within 56 days prior to enrollment
• •16. Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
• •17. Active drug, alcohol or nicotine use or dependence or any condition that, in the opinion of the Investigator, would interfere with adherence to study protocol