Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production

A Phase I, Open-label, Fixed-order, Single-dose, 2-Part, Crossover Study to Evaluate the Pharmacokinetics of a Formulation of Tricaprilin (AC-SD-01) Including the Effect of Food on Ketone Body Production in Caucasians and Asians

This is a Phase I, single center, open label, fixed-order, crossover, food-effect, pharmacokinetic (PK) study recruiting healthy, adult, male subjects.

Inclusion Criteria:

• Healthy adult male, ages 18 - 55
• Able to consume a regular diet and one high fat meal; no specific dietary requirements
• Cohort 2 (Asian subject population) restricted to being of Japanese or Chinese heritage

Exclusion Criteria:

• Presence of any illness or condition that, in the opinion of the investigator might confound the study results or poses risk to the subject
• Has been on a ketogenic diet as supported by review of a food diary
• Has positive Urine Drug Screen or alcohol results at Screening