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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
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To compare serum ketone body (i.e., total ketones and β-hydroxybutyrate) levels after administration of AC-1204 versus caprylic triglyceride (CT) oil, both after a standard breakfast.
To evaluate the effect of a high fat diet on serum ketone body levels after administration of CT oil with a high fat breakfast versus a standard breakfast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group ABC | Experimental | AC-1204, caprylic triglyceride oil standard breakfast, caprylic triglyceride high fat breakfast |
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| Group BCA | Experimental | caprylic triglyceride oil standard breakfast, caprylic triglyceride high fat breakfast, AC-1204 |
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| Group CAB | Experimental | caprylic triglyceride high fat breakfast, AC-1204, caprylic triglyceride oil standard breakfast |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC-1204 | Drug | 40 g (120 mL) AC-1204 administered 30 minutes after the start of a standard breakfast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| total ketones AUC0-t | The area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method. | 0-24 hours |
| total ketones AUC0-inf | The area under the concentration-time curve from time 0 extrapolated to infinity. AUC0-inf is calculated as the sum of AUC0-t plus the ratio of the last measurable serum concentration to the elimination rate constant. | 0-24 hours |
| total ketones AUC%extap | Percent of AUCo-inf extrapolated, represented as (1 - AUC0-t/AUC0- inf)*100 | 0-24 hours |
| total ketones Cmax | Maximum observed concentration | 0-24 hours |
| total ketones Kel | Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the serum concentration versus time curve. The parameter will be calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase (e.g., three or more non-zero serum concentrations) | 0-24 hours |
| total ketones T 1/2 | Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel | 0-24 hours |
| total ketones Tmax | Time to reach Cmax. If the maximum value occurs at more than one time point, Tmax is defined as the first time point with this value |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geri Poss, MD | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc | Tempe | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| C003637 | tricaprylin |
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| caprylic triglyceride oil (standard breakfast) | Drug | 20 g CT oil (21 mL) administered 30 minutes after the start of a standard breakfast. |
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| caprylic triglyceride oil (high fat breakfast) | Drug | 20 g CT oil (21 mL) administered 30 minutes after the start of a high fat breakfast. |
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| 0-24 hours |
| β-hydroxybutyrate AUC0-t | The area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method. | 0-24 hours |
| β-hydroxybutyrate AUC0-inf | The area under the concentration-time curve from time 0 extrapolated to infinity. AUC0-inf is calculated as the sum of AUC0-t plus the ratio of the last measurable serum concentration to the elimination rate constant | 0-24 hours |
| β-hydroxybutyrate AUC%extap | Percent of AUCo-inf extrapolated, represented as (1 - AUC0-t/AUC0- inf)*100. | 0-24 hours |
| β-hydroxybutyrate Cmax | Maximum observed concentration | 0-24 hours |
| β-hydroxybutyrate Tmax | Time to reach Cmax. If the maximum value occurs at more than one time point, Tmax is defined as the first time point with this value | 0-24 hours |
| β-hydroxybutyrate Kel | Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the serum concentration versus time curve. The parameter will be calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase (e.g., three or more non-zero serum concentrations). | 0-24 hours |
| β-hydroxybutyrate T 1/2 | Apparent first-order terminal elimination half-life will be calculated as 0.693/kel. | 0-24 hours |