Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production

Cerecin20 enrolled

Overview

This is a Phase I, single center, open label, fixed-order, crossover, food-effect, pharmacokinetic (PK) study recruiting healthy, adult, male subjects.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Alzheimer Disease

Interventions

tricaprilinDRUG

Tricaprilin formulated as AC-SD-01

standard mealOTHER

standard meal

high-fat mealOTHER

high-fat meal

overnight fast

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adult male, ages 18 - 55 * Able to consume a regular diet and one high fat meal; no specific dietary requirements * Cohort 2 (Asian subject population) restricted to being of Japanese or Chinese heritage Exclusion Criteria: * Presence of any illness or condition that, in the opinion of the investigator might confound the study results or poses risk to the subject * Has been on a ketogenic diet as supported by review of a food diary * Has positive Urine Drug Screen or alcohol results at Screening

Locations (1)

Nucleus Network

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

Total ketones

Area Under the Curve (AUC) AUC 0-last

Time frame: 1 day

Total ketones

AUC 0 - 4

Time frame: 1 day

Total ketones

AUC 0 - 6

Time frame: 1 day

Total ketones

AUC 0-8

Time frame: 1 day

Total ketones

Maximum Plasma Concentration (Cmax)

Time frame: 1 day

B-hydrodxybutyrate

AUC 0-last

Time frame: 1 day

B-hydroxybutyrate

AUC 0-4

Time frame: 1 day

B-hydroxybutyrate

AUC 0-6

Time frame: 1 day

B-hydroxybutyrate

AUC 0-8

Time frame: 1 day

B-hydroxybutyrate

Cmax

Time frame: 1 day

Acetoacetate

AUC 0-last

Time frame: 1 day

Acetoacetate

Data from ClinicalTrials.gov

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Secondary Outcomes

tricaprilin

AUC 0 - last

Time frame: 1 day

tricaprilin

AUC 0 - 4

Time frame: 1 day

tricaprilin

AUC 0 - 6

Time frame: 1 day

tricaprilin

AUC 0 - 8

Time frame: 1 day

tricaprilin

Time to maximum concentration (Tmax)

Time frame: 1 day

tricaprilin

Cmax

Time frame: 1 day

octanoic acid

AUC 0 - last

Time frame: 1 day

octanoic acid

AUC 0 - 4

Time frame: 1 day

octanoic acid

AUC 0 - 6

Time frame: 1 day

octanoic acid

AUC 0 - 8

Time frame: 1 day

octanoic acid

Tmax

Time frame: 1 day

octanoic acid

Cmax

Time frame: 1 day

Computerized Cognitive Battery - Attention

Rapid Visual Information Processing Test

Time frame: 1 day

Computerized Cognitive Battery - Episodic Memory

Paired Associates Learning Test

Time frame: 1 day

Computerized Cognitive Battery - Working Memory

Spatial Working Memory Test

Time frame: 1 day

Computerized Cognitive Battery - Psychomotor Function

Reaction Time Test

Time frame: 1 day