Relative Bioavailibilty for Pediatric Powder for Suspension (PfOS) Formulation and Food Effect

Exclusion Criteria

• •1. History of Gilbert's syndrome.
• •2. Any previous history of deep vein thrombosis or any other thromboembolic event.
• •3. History of thrombocytopenia or bleeding due to abnormal platelet number or function.
• •4. Clotting factor abnormalities associated with hypercoagulability, specifically Factor V Leiden, Protein C or Protein S deficiency or antithrombin III deficiency.
• •5. Elevated blood pressure (BP) at screening (systolic \> 140 mm Hg, diastolic \> 85 mm Hg). If the subject's BP is elevated on the first measurement, complete two additional BP measurements two minutes apart and average the three assessments to evaluate this criteria. If averaged BP exceeds the safety criteria, the subject should be excluded.
• •6. History of atrial fibrillation, mitral valve prolapse, significant heart murmur or vascular bruit.
• •7. Prolonged QTc interval (Bazett's) at screening (for females \> 450 msec and for males \> 430 msec). If the QTc interval is prolonged on the initial ECG, then complete two additional ECGs 5 minutes apart and take the average QTc measurements of all three ECGs to evaluate this criteria. If averaged QTc exceeds the safety criteria, the subject should be excluded.
• •8. Female subjects currently receiving hormone replacement therapy (HRT).
• •9. Positive for HIV, hepatitis B virus or hepatitis C virus assays at screening.
• •10. Positive urine drug screen including alcohol at screening or pre-dose (Day -1).
• •11. History of alcohol/drug abuse or dependence within 12 months of the study.
• •12. History of alcohol consumption in the past six months exceeding 7 units/week for women and 14 units/week for men (where 1 unit = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor).
• •13. Urinary cotinine levels indicative of smoking at screening or pre-dose (Day -1). History of regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
• •14. Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication.
• •15. Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
• •16. Use of prescription or non-prescription drugs (including aspirin and non-steroidal anti-inflammatory drugs \[NSAIDs\]), vitamins, herbal and dietary supplements within seven days (or 14 days if the drug is a potential enzyme inducer, such as St. John's Wort) or five half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety.
• •17. Subjects who have donated plasma within seven days prior to the screening visit or where participation in this study would result in donation of blood in excess of 500 mL within a 56-day period.
• •18. History of sensitivity to any of the study medications, or components thereof.