Phase I Trial of an Investigational Small Pox Medication

Exclusion Criteria

• •1. Marked baseline prolongation of QT/corrected QT interval (QTc) interval (
• •2. History of additional risk factors for Torsade de Pointes
• •3. Clinically significant abnormal ECG
• •4. Personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or prolongation of the PR interval
• •5. Family history of Sudden Cardiac Death not clearly due to acute myocardial infarction.
• •6. History of any clinically significant conditions including:
• •* Asthma
• •* Diabetes mellitus
• •* History of thyroidectomy or thyroid disease
• •* Serious angioedema episodes
• •* Head trauma resulting in a diagnosis of TBI other than concussion
• •* Seizure or history of seizure
• •* Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with intramuscular injections or blood draws
• •* Malignancy
• •7. Family history of idiopathic seizures
• •8. History or presence of neutropenia or other blood dyscrasia
• •9. Known Hepatitis B or Hepatitis C infection
• •10. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome illness.
• •11. Current or recent history of a clinically significant bacterial, fungal, or mycobacterial infection.
• •12. Known clinically significant chronic viral infection (or current clinically significant viral infection
• •13. History of frequent or severe headaches or migraines
• •14. Known chronic bacterial, mycobacterial, fungal, parasitic, or protozoal infection
• •15. Woman who is pregnant or is breast-feeding or planning to become pregnant
• •16. On any concomitant medications
• •17. History of drug allergy that, in the opinion of the PI, contraindicates participation in the trial.
• •18. Inability to swallow medication
• •19. Body Mass Index above 35 or below 18,
• •20. Current drug abuse or alcohol abuse.
• •21. Inability to refrain from physical exercise for a period of 24 hr before and after a PK day or refrain from consuming xanthines, grapefruit or grapefruit juice
• •22. Clinically significant lactose intolerance
• •23. Received experimental drug within 30 days
• •24. Vaccination within 30 days
• •25. Total of more than 350 milliliters (mL) of blood drawn in 2 months
• •26. Treatment with any immunosuppressant or immunomodulatory medication in 3 months
• •27. Any condition occupational reason or other responsibility that, in the judgment of the PI, would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol
• •28. History or diagnosis that would affect absorption of study medication