Evaluation of PK of Caprylic Triglyceride Oil, AC-1202, AC-1204, and Axona on Ketone Body Production

Exclusion Criteria

• •1. Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
• •2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
• •3. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
• •4. History or presence of alcoholism or drug abuse within the past 2 years prior to Day -1 of Period 1.
• •5. History or presence of hypersensitivity or idiosyncratic reaction to the study drugs, related compounds, milk, palm or coconut oil, or soy.
• •6. History or presence of diverticular disease, ulcers, inflammatory bowel disease or recurrent diarrhea or gout.
• •7. Positive urine drug or alcohol results at screening or check in.
• •8. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
• •9. Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
• •10. Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.
• •11. QTcF interval is \>460 msec or has ECG findings deemed abnormal with clinical significance by the PI or designee at screening.
• •12. Estimated creatinine clearance ≤80 mL/min at screening.
• •13. Unable to refrain from or anticipates the use of any drug, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to Day -1 of Period 1 and throughout the study. Acetaminophen (up to 2 g per 24 hour period) may be permitted during the study.
• •14. Has been on a diet incompatible with the on study diet, in the opinion of the PI or designee, within the 28 days prior to Day -1 of Period 1 and throughout the study.
• •15. Is lactose intolerant.
• •16. Is unable to complete the meal prior to Day -1 of Period 1.
• •17. Subject consumed grapefruit or Seville oranges within 14 days prior to Day -1 of Period 1.
• •18. Donation of blood or significant blood loss within 56 days prior to Day -1 of Period 1.
• •19. Plasma donation within 7 days prior to Day -1 of Period 1.
• •20. Participation in another clinical study within 28 days prior to Day -1 of Period 1. The 28 day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day -1 of Period 1 of the current study.