Study to Compare the Pharmacokinetics of Daily Administration of Tricaprilin on Ketone Body Production

Inclusion criteria

• Healthy, adult, males or females, age 50 years and above, at Screening.
• Subject must be in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination (including blood pressure and pulse rate measurement), 12 lead ECG and clinical laboratory tests. Subjects with mild, chronic, stable disease (e.g., controlled hypertension, Type 2 diabetes, etc) will be permitted to enrol.
• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening.
• Agrees to comply with study procedures including the confinement period of 28 days.
• Subject is able and willing to consume a prescribed full breakfast, lunch and dinner while confined in the CRU. Subject does not have specific dietary requirements (vegetarian, vegan, lactose-free, low-fat, etc.).
• Subject is not consuming a ketogenic diet (defined by consumption of < 50 gm carbohydrates per day).
• A non vasectomized male subject must agree to use a condom or abstain from sexual intercourse during the study and for 90 days following last dose of AC-SD 03. No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to Screening. A subject who has been vasectomized less than 4 months prior to Screening must follow the same restrictions as a non vasectomized male.
• Female subjects must be either surgically sterile or 2 or more years post-menopause.
• Has given voluntary, written informed consent to participate in the study.

Exclusion criteria

• History or presence of alcoholism or substance abuse disorder within the last year.
• Positive urine drug screen at Screening or Check-In.
• Subject is currently actively using MCTs, ketone esters, or other ketogenic products or is following a ketogenic diet.
• Clinically significant abnormal laboratory results at Screening that in the opinion of the PI preclude participating in this study
• Participation in another clinical trial within 30 days prior to Check-In.
• Subject has a known allergy to the study drug's active or inactive ingredients.
• Subject has been following a ketogenic diet (or other diet incompatible with the on-study diet), in the opinion of the investigator.
• Unable to refrain from, or anticipates the use of drugs other than allowed products, including prescription and non-prescription medications, beginning 14 days prior to the first dose and throughout the study.

• Allowed medications include anti-hypertensive agents, statins, aspirin in a dose of 100 mg or less per day for prophylaxis.
• Paracetamol (acetaminophen), up to 4 g per 24 hour period, or ibuprofen (up to 1200 mg per 24-hour period) may be permitted during the study.
• Herbal remedies and vitamin supplements are permitted in usual doses (not hyper supplementation) so long as subject has been on stable amounts for at least 6 weeks.
• Agents being taken to improve memory or cognition are not allowed, whether herbal, 'natural' or pharmaceutical.
• Subject is known HIV, HBV or HCV positive, or has a positive test at Screening.
• Any other condition which, in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.