An Open-label, Single-dose, Non-randomized Study of IV 14C-labeled PER977 in Healthy Male Subjects

Exclusion Criteria

• •1. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any condition which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results
• •2. Clinically significant abnormal finding on the physical exam, medical history, electrocardiogram or clinical laboratory resutls at screening
• •3. History or presence of allergic or adverse response to anticoagulant reversal agents or related drugs
• •4. Significantly abnormal diet within 4 weeks
• •5. Donated blood or plasma within 30 days
• •6. Participated in another clinical trial (randomized subjects only) within 30 days
• •7. Participated in a radiolabeled clinical trial within the last 12 months
• •8. Used any over-the-counter medication, including nutritional supplements, within 7 days
• •9. Used any prescription medication within 14 days prior
• •10. Treated with any known drugs that are moderate or strong inhibitors/inducers of CYP enzymes such as barbiturates,phenothiazines, cimetidine, carbamazepine, etc. within 30 days
• •11. Smoked or used tobacco products within 60 days
• •12. History of substance abuse or treatment (including alcohol ) within the past 2 years
• •13. Positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates) or cotinine at screening or check-in
• •14. Positive test for hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus at screening or has previously been treated for hepatitis B, hepatitis C or HIV infection
• •15. Has irregular bowel habits
• •16. Has had significant radiation exposure within the prior 12 months