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

Phase 1CompletedNCT05408780

Cerecin45 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Alzheimer Disease

Interventions

AC-OLE-01-VADRUG

formulation of tricaprilin or matching placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Quotient Sciences Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

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)

AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)

Time frame: 0 to 8 hours post-dose

Incidence of Treatment Emergent Adverse Events (Part B)

Adverse event incidence will be tabulated

Time frame: Baseline to 28 days

Secondary Outcomes

Incidence of Treatment Emergent Adverse Events (Part A)

Adverse event incidence will be tabulated \[BARF\] Scale)

Time frame: Baseline to 8 days

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)

AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)

Time frame: 0 to 8 hours post-dose

Maximum observed concentration (Cmax) of total ketones (β-hydroxybutyrate and acetoacetate) after administration of tricaprilin and placebo formulations (Part A, Part B)

Cmax will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)

Time frame: 0 to 8 hours post-dose

Data from ClinicalTrials.gov

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