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

Cerecin

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: AC-OLE-01-VA

Study type: Interventional

Funder types: Industry

Identifiers

NCT05408780

AC-22-028

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups

Part A - Food Effect Assessment

Experimental group

Description:

Subjects will be randomized before administration of the first dose of active or matching placebo IMP in a 1:1:1:1 ratio to 1 of 4 treatment sequences (ABCD, BACD, ABDC, BADC) so that all subjects receive Regimens A, B, C and D across the 4 periods.

Treatment:

Drug: AC-OLE-01-VA

Part B - Titration Tolerability

Experimental group

Description:

Subjects will be dosed BID in the morning and afternoon (approximately 5 h apart) on Days 1 to 27. Both doses of active or matching placebo IMP will be administered in the fed state either 30 min after completion of a standard-fat and calorie content breakfast or 30 min after a standardized-fat and calorie content lunch. Participants will be randomised to either study drug or the matching placebo.

Treatment:

Drug: AC-OLE-01-VA