A Phase 1, Two-part, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Liquid Formulation of Tricaprilin and Matching Placebo in Healthy Subjects

A Phase 1, Two-part, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Liquid Formulation of Tricaprilin, and Matching Placebo to Include Single-dose and Food Effect (Part A), and Titration Tolerability (Part B), in Healthy Subjects

The purpose of this study is to evaluate the PK, safety, and tolerability of a new liquid formulation of tricaprilin.

Main Inclusion Criteria:

• Healthy males and non-pregnant, non-lactating healthy females aged 18 to 55 years inclusive at time of signing informed consent with a body weight ≥55 kg.
• Body mass index (BMI) 18.0 to 32.0 kg/m2 as measured at screening or, if outside the range, considered not clinically significant by the investigator.

Main Exclusion Criteria:

• Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
• Subjects with a history of fainting, dizziness, bradycardia or hypotension as considered clinically significant by the investigator
• Subject has a medical condition that may adversely affect taste or smell activity