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

AC-22-028

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

2022-07-14

2022-08-13

2022-10-24

Completed

Early phase I

45

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a two-part study.\n\nPart A (Food Effect Assessment): It is a randomized, double-blind (to IMP received), placebo-controlled, four-period, single-dose design. Subjects will be dosed in the fed state or the fasted state depending on the regimen.\n\nPart B (Titration Tolerability): Participants will be administered to either tricaprilin or a matching placebo.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 45, 'type': 'ACTUAL'}}

2023-10-17