Safety, Tolerability, and Pharmacokinetics of Oral EC5026 in Healthy Subjects

Exclusion Criteria

• •Subjects meeting any of the following criteria will be excluded from the study:
• •1. The subject has any abnormalities in any of the following: liver function tests, CPK, or urinalysis results. Liver function tests, CPK, or urinalysis tests may be repeated at the discretion of the investigator, if necessary, to confirm any abnormalities.
• •2. The subject has used any nonstudy medication(s), including low-dose aspirin for cardiovascular prophylaxis, within 1 week before administration of study drug.
• •3. The subject has used chemotherapy agents or has a history of cancer, other than nonmetastatic skin cancer that has been completely excised, within 5 years prior to screening.
• •4. The subject has a history of bacterial, fungal, or viral infection requiring treatment with antibiotics, antifungal agents, or antivirals within 1 month prior to randomization.
• •5. The subject has a presence or history of peripheral edema within the past 5 years.
• •6. The subject has a history of congestive heart failure.
• •7. The subject has used drugs which are CYP inducers or inhibitors within 30 days of randomization (eg, cimetidine, paroxetine, fluoxetine, haloperidol, ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin).
• •8. The subject has used any dietary aids, supplements, or foods that are known to modulate drug metabolizing enzymes (eg, St. John's wort, grapefruit juice) within 14 days of administration of study drug.
• •9. The subject has difficulty in swallowing oral medications.
• •10. The subject has a history of seizure disorder.
• •11. The subject has serious psychosocial comorbidities as determined by the principal investigator.
• •12. The subject has cognitive or psychiatric disorders, or any other condition that could interfere with compliance with study procedures and/or confinement in a study unit for 5.5 days.
• •13. The subject has a history of drug or alcohol abuse within 1 year prior to Screening.
• •14. The subject has used any other investigational drug within 1 month or 5 half-lives, whichever is longer, prior to randomization.
• •15. The subject has used prescription drugs within 1 month or 5 half-lives, whichever is longer, prior to randomization.
• •16. The subject has used over-the-counter medication excluding routine vitamins, but including mega-dose vitamin therapy, within 1 week prior to randomization.
• •17. The subject has donated and/or received any blood or blood products (more than 450 mL) within 3 months prior to randomization.
• •18. The subject has a presence or history of active gastrointestinal, renal, hepatic, or coagulant disorder within 1 month prior to randomization.
• •19. The subject has a presence or history of esophageal or gastroduodenal ulceration within 1 month prior to randomization.
• •20. The subject has a family history of significant cardiac disease (ie, sudden death in first degree relative; myocardial infarction prior to 50 years