Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246

Exclusion Criteria

• •1. Inability to swallow study medication
• •2. Pregnant or breast-feeding
• •3. Medical condition, e.g., asthma, hypertension, angioedema, traumatic brain injury other than concussion, bleeding disorder, blood dyscrasia, idiopathic seizures, cardiac disease that limits activity, diabetes, active malignancy, Hepatitis B or C, HIV or AIDS, chronic microbial infection,
• •4. History of drug allergy that contraindicates study participation
• •5. Medical, psychiatric, social, occupational or other reason that jeopardizes the safety/rights of participant or renders he/she unable to comply with the protocol (including drug or alcohol abuse, or homelessness)
• •6. Clinically abnormal ECG
• •7. Has or will participate in a clinical trial or experimental treatment within 30 days of, or during, the study
• •8. Cannot or will not do physical exercise 24 hrs before and after PK days
• •9. Will not consume grapefruit/grapefruit juice during study
• •10. Vaccination within 2 wks of screening, or planned before Day 42 of study
• •11. Treatment with prednisone or equivalent immunosuppressant/modulatory drug \<3 mths before screening
• •12. Clinically significant physical exam and lab results \<2weeks from 1st study drug dose