A Phase I Randomized, Double-Blind, Crossover, Exploratory Study of the Pharmacokinetics of a Single Oral Dose of Form I Versus Form V Capsules of the Anti-Orthopoxvirus Compound ST-246® in Fed Normal Healthy Volunteers

Fecha de inicio: 1 de agosto de 2008

Inclusion Criteria: 1. 18 to 50 years 2. Available for clinical follow-up duration of study. 3. Able/willing to give written consent. 4. Good general health; no clinically significant medical history. 5. Refrain from taking any medications from screening through 72 hours after last dose. 6. Adequate venous access. 7. PE and lab results without clinically significant findings within 28 days prior to receipt of drug. 8. Meet Lab Criteria within 28 days prior to receipt of drug. 9. Negative pregnancy test 10. Non smokers 11. No alcohol or caffeine 12. Participant or partner has undergone surgical sterilization, or the participant agrees either to be abstinent or use two non-hormonal methods of contraception for duration of the study 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