Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production

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

Official Title
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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

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Drug: tricaprilin
* Other: standard meal
* Other: high-fat meal
* Other: overnight fast


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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