Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production

A Phase I, Open-label, Fixed-order, Single-dose, 2-Part, Crossover Study to Evaluate the Pharmacokinetics of a Formulation of Tricaprilin (AC-SD-01) Including the Effect of Food on Ketone Body Production in Caucasians and Asians

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

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: tricaprilin; Other: standard meal; Other: high-fat meal; Other: overnight fast

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Nucleus Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1, Period 1; Study drug administered concurrently with a standard meal	Drug: tricaprilin; Tricaprilin formulated as AC-SD-01; Other: standard meal; standard meal
Experimental: Cohort 1, Period 2; Study drug administered 30 minutes after a standard meal	Drug: tricaprilin; Tricaprilin formulated as AC-SD-01; Other: standard meal; standard meal
Experimental: Cohort 1, Period 3; Study drug administered 30 minutes after a high-fat meal	Drug: tricaprilin; Tricaprilin formulated as AC-SD-01; Other: high-fat meal; high-fat meal
Experimental: Cohort 1, Period 4; Study drug administered after an overnight fast	Drug: tricaprilin; Tricaprilin formulated as AC-SD-01
Experimental: Cohort 2, Period 1; Study drug administered 30 minutes after a standard meal (Asian)	Drug: tricaprilin; Tricaprilin formulated as AC-SD-01; Other: standard meal; standard meal
Experimental: Cohort 2, Period 2; Study drug administered after an overnight fast (Asian)	Drug: tricaprilin; Tricaprilin formulated as AC-SD-01; Other: overnight fast; fasting for at least 9 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total ketones	AUC 0 - 4	1 day
Total ketones	AUC 0 - 6	1 day
Total ketones	Maximum Plasma Concentration (Cmax)	1 day
B-hydroxybutyrate	Cmax	1 day
Acetoacetate	Cmax	1 day
Total ketones	Area Under the Curve (AUC) AUC 0-last	1 day
Total ketones	AUC 0-8	1 day
B-hydrodxybutyrate	AUC 0-last	1 day
B-hydroxybutyrate	AUC 0-4	1 day
B-hydroxybutyrate	AUC 0-6	1 day
B-hydroxybutyrate	AUC 0-8	1 day
Acetoacetate	AUC 0-last	1 day
Acetoacetate	AUC 0-4	1 day
Acetoacetate	AUC 0-6	1 day
Acetoacetate	AUC 0-8	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tricaprilin	AUC 0 - last	1 day
tricaprilin	AUC 0 - 4	1 day
tricaprilin	AUC 0 - 6	1 day
tricaprilin	AUC 0 - 8	1 day
tricaprilin	Time to maximum concentration (Tmax)	1 day
tricaprilin	Cmax	1 day
octanoic acid	AUC 0 - last	1 day
octanoic acid	AUC 0 - 4	1 day
octanoic acid	AUC 0 - 6	1 day
octanoic acid	AUC 0 - 8	1 day
octanoic acid	Tmax	1 day
octanoic acid	Cmax	1 day
Computerized Cognitive Battery - Attention	Rapid Visual Information Processing Test	1 day
Computerized Cognitive Battery - Episodic Memory	Paired Associates Learning Test	1 day
Computerized Cognitive Battery - Working Memory	Spatial Working Memory Test	1 day
Computerized Cognitive Battery - Psychomotor Function	Reaction Time Test	1 day

Collaborators and Investigators

• Sponsor: Cerecin

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2018
• Primary Completion (Actual): August 16, 2018
• Study Completion (Actual): August 27, 2018

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: May 29, 2018
• First Posted (Actual): June 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 27, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: AC-18-016_FE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No