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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05408780

Enrollment

Registered

2022-06-07

Start date

2022-07-14

Completion date

2022-10-24

Last updated

2023-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Brief summary

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

Interventions

DRUGAC-OLE-01-VA

formulation of tricaprilin or matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

This is a two-part study. Part 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. Part B (Titration Tolerability): Participants will be administered to either tricaprilin or a matching placebo.

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part A)	0 to 8 hours post-dose	AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
Incidence of Treatment Emergent Adverse Events (Part B)	Baseline to 28 days	Adverse event incidence will be tabulated

Secondary

Measure	Time frame	Description
Incidence of Treatment Emergent Adverse Events (Part A)	Baseline to 8 days	Adverse event incidence will be tabulated \[BARF\] Scale)
Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) of tricaprilin and placebo formulations following a titration scheme (Part B)	0 to 8 hours post-dose	AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
Maximum observed concentration (Cmax) of total ketones (β-hydroxybutyrate and acetoacetate) after administration of tricaprilin and placebo formulations (Part A, Part B)	0 to 8 hours post-dose	Cmax will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026