Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03551769
• Other study ID #: AC-18-016_FE
• Status: Completed
• Phase: Phase 1
• Start date: August 5, 2018
• Est. completion date: August 27, 2018

Study information

• Verified date: May 2019
• Source: Cerecin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 27, 2018
• Est. primary completion date: August 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• tricaprilin
Tricaprilin formulated as AC-SD-01

Other:
• standard meal
standard meal
• high-fat meal
high-fat meal
• overnight fast
fasting for at least 9 hours

Locations

Country	Name	City	State
Australia	Nucleus Network	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Cerecin

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total ketones	Area Under the Curve (AUC) AUC 0-last	1 day
Primary	Total ketones	AUC 0 - 4	1 day
Primary	Total ketones	AUC 0 - 6	1 day
Primary	Total ketones	AUC 0-8	1 day
Primary	Total ketones	Maximum Plasma Concentration (Cmax)	1 day
Primary	B-hydrodxybutyrate	AUC 0-last	1 day
Primary	B-hydroxybutyrate	AUC 0-4	1 day
Primary	B-hydroxybutyrate	AUC 0-6	1 day
Primary	B-hydroxybutyrate	AUC 0-8	1 day
Primary	B-hydroxybutyrate	Cmax	1 day
Primary	Acetoacetate	AUC 0-last	1 day
Primary	Acetoacetate	AUC 0-4	1 day
Primary	Acetoacetate	AUC 0-6	1 day
Primary	Acetoacetate	AUC 0-8	1 day
Primary	Acetoacetate	Cmax	1 day
Secondary	tricaprilin	AUC 0 - last	1 day
Secondary	tricaprilin	AUC 0 - 4	1 day
Secondary	tricaprilin	AUC 0 - 6	1 day
Secondary	tricaprilin	AUC 0 - 8	1 day
Secondary	tricaprilin	Time to maximum concentration (Tmax)	1 day
Secondary	tricaprilin	Cmax	1 day
Secondary	octanoic acid	AUC 0 - last	1 day
Secondary	octanoic acid	AUC 0 - 4	1 day
Secondary	octanoic acid	AUC 0 - 6	1 day
Secondary	octanoic acid	AUC 0 - 8	1 day
Secondary	octanoic acid	Tmax	1 day
Secondary	octanoic acid	Cmax	1 day
Secondary	Computerized Cognitive Battery - Attention	Rapid Visual Information Processing Test	1 day
Secondary	Computerized Cognitive Battery - Episodic Memory	Paired Associates Learning Test	1 day
Secondary	Computerized Cognitive Battery - Working Memory	Spatial Working Memory Test	1 day
Secondary	Computerized Cognitive Battery - Psychomotor Function	Reaction Time Test	1 day