Evaluation of PK of AC1204 v Caprylic Triglyceride Oil Incl Food Effect on Ketone Body Production

Inclusion Criteria:

1. Healthy, adult, male 18-55 years of age, inclusive, at screening.

2. Continuous non-smoker who has not used nicotine-containing products for at least 3
months prior to the first dose and throughout the study.

3. Body mass index (BMI) ≥ 20.0 and ≤ 30.0 kg/m2 at screening.

4. Medically healthy with no clinically significant medical history, physical
examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or
designee. At screening, subjects must have alanine aminotransferase (ALT), aspartate
aminotransferase (AST) and alkaline phosphatase (ALP) < the upper limit of normal and
triglycerides levels < 250 mg/dL.

5. A non-vasectomized subject must agree to use a condom with spermicide or abstain from
sexual intercourse during the study until 90 days beyond the last dose of study drug.
(No restrictions are required for a vasectomized male provided his vasectomy has been
performed 4 months or more prior to first dose/dosing of study drug. A subject who
has been vasectomized less than 4 months prior to study first dose/dosing must follow
the same restrictions as a non-vasectomized male).

6. Subjects must agree not to donate sperm from the first dose/dosing until 90 days
after dosing.

7. Understands the study procedures in the informed consent form (ICF), and be willing
and able to comply with the protocol.

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 the
first dose/dosing.

5. History or presence of hypersensitivity or idiosyncratic reaction to the study drugs,
related compounds, milk, 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. QTc interval is >460 msec (males) 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 the first dose and throughout the study. Acetaminophen (up to 2 g per
24 hour period) and medications for the treatment of adverse events 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 the first dose and throughout the study.

15. Is lactose intolerant.

16. Is unable to complete the critical meal (i.e., breakfast prior to dosing).

17. Donation of blood or significant blood loss within 56 days prior to the first dose.

18. Plasma donation within 7 days prior to the first dose.

19. Participation in another clinical study within 28 days prior to the first dose. 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.